Important Safety Information on Hospira Devices that have Defective AC Power Cords

Starting date:

September 25, 2009

Posting date:

October 1, 2009

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002043

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This is duplicated text of a letter from Hospira Healthcare Corporation.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Hospira Devices that have Defective AC Power Cords

September 25, 2009

Subject: Medical Device Recall for certain Hospira devices that have defective AC power cords

Dear Health Care Professional,

Hospira is conducting a recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports outside Canada of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. Hospira has not received any reports of serious patient harm related to the situation.

This recall is limited to device power cords with a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug (see Figure 1). Devices with power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected (see Figure 2). Electri-Cord has identified the root cause of the issue and has implemented necessary design changes to reduce the likelihood of recurrence.

Hospira recommends you take the following immediate actions to locate affected AC power cords:

1. Check all affected devices and spare parts inventory to determine if the specified AC power cords are in use at your facility (see Figure 1).
2. For affected power cords not exhibiting any of the characteristics described above, please continue to monitor those power cord plugs closely until you receive replacement power cords. Should you have any Clinical questions, please do not hesitate to contact Clinical Support at 1-866-488-6088, option 4.
3. For affected AC power cords, inspect for any bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear.
4. For those cords exhibiting bent or cracked prongs and/or bridge connection, burnt plastic or excessive wear and tear, please immediately discontinue use and contact Hospira Technical Support at 1-866-488-6088, option 5.  Hospira will contact your facility to schedule replacement activities in the very near future.

Hospira is not asking that you immediately return affected power cords or devices. Service activities will begin in an expedious matter, and will continue until all replacement activity is complete. Hospira will replace all affected power cords regardless of their condition. Hospira will provide replacement cords and resources to assist with replacement upon request.

Please complete and return the attached Reply Form after your facility has completed its review for affected AC power cords.

Please forward this notice to all departments within your facility using devices with Electri-Cord power cords and to any third parties to whom your facility may have sold or shipped Hospira devices with affected power cords.

This correction is being made with the knowledge of Health Canada.

Table 1. Potentially-affected Hospira devices

Product Name	List Number
LIFECARE PCA 4100 PLUS INFUSER	1950
LIFECARE 5000 PLUM INFUSION PUMP SYSTEM	2507
PLUM XL	11555
PLUM XL 3 MULTI-LINE INFUSION SYSTEM (XL3)	11781
PLUM XL 3 MICRO/MACRO INFUSION SYSTEM (XL3M)	11845
PLUM XL MICRO/MACRO INFUSION SYSTEM (XLM)	11846
PLUM XL MICRO/MACRO INFUSION WITH DATA PORT (XLD)	11859
PLUM A+ VOLUMETRIC INFUSION PUMP	11971 / 12391
LIFECARE PCA 3 INFUSION SYSTEM	12384
PLUM A+3 INFUSION PUMPS	12618
PLUM A+3 INFUSION PUMPS WITH MEDNET	20678
PLUM A+ VOLUMETRIC INFUSION PUMP	20679 / 20792
LIFECARE PCA 3 INFUSION SYSTEM	20709
GEMSTAR AC WALL ADAPTER	13072
GEMTAR DOCKING STATION	13075
NUTRIMIX MICRO COMPOUNDERN	11365
OMNI-FLOW 4000 PLUS IV MEDICATION MANAGEMENT SYSTEM	40051
OPTIONAL THERMA PRINTER	50132
OXIMETRIX 3 SYSTEM S02/CO COMPUTER	50130

Figure 1: Affected Plug.

Affected cords contain a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug.

Figure 2: Not Affected Plug.

Power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious specific adverse incident or other serious adverse incidents in patients using Hospira devices that have defective AC power cords should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips Boulevard, Suite 600
Saint-Laurent, Québec
H4M 2X6
Tel. 1-866-488-6088

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

original signed by
Beryl Chan
Director, Scientific Affairs
Hospira Healthcare Corporation

Urgent Device Recall for AC Power Cords

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Reply Form

1.  Are there additional locations or entities that may have received the affected cords?

• Yes
• No

If yes, please list the contact information below and Hospira will notify them directly.

• Name:
• Address:
• City/State/Zip:
• Contact Name:
• Phone:

2. I would like to request Hospira resources to replace my detachable cords.

• Yes
• No

Hospira will contact you for service scheduling in the near future

3. I have identified any Hospira devices that have AC power cords which were replaced with non-Hospira supplied cords.

• Yes
  • Number of Cords:
• No
  • Please explain:

4. Page numbers being faxed back:

• All
• 1
• 2
• 3
• 4
• 5

• Replacement Cord(s) Ship to:
• Firm/Facility Name:
• Hospira Customer #:
• Address:
• City/State/Zip:
• Contact Name:
• Phone:
• Department:
• Reply Form Completed By:
• Title:
• Dept:
• Printed Name:
• Signature/Date:

Please fax 5 pages of the completed form to Hospira at 1-877-906-0208

Urgent Device Recall for AC Power Cords

Reply Form - August 26, 2009

AC Power Cords manufactured by Electri-Cord Manufacturing Corp. on the following Hospira Devices:

Please fax all 5 pages of the completed form to 1-877-906-0208

Hospira will provide replacement cords and resources to assist with replacement upon request. To assist in expediting this process, please check your inventory and complete the information below. The product identity label located on the back of the device will contain the applicable list number referenced below.

The product identity label located on the back of the device will contain the applicable list number referenced below.

Product Description	List Number	Number of Out of Service, Affected Cords for Immediate Replacement	Number of In use (monitoring), Affected Cords for Replacement
GemStar AC Wall (Mains) Adapter (90-260 Volts-universal)	13072-04-01
GemStar Docking Station  (90-260 Volts)	13075-04-01
	13075-04-03
	13075-04-05
	13075-04-07
LifeCare PCA Plus II	01950-04-01
	01950-04-02
	01950-04-03
	01950 04-05
	01950-04-06
	01950-04-07
	01950-04-08
	01950-13-07
	01950-13-08
LifeCare PCA 3	12384-04-05
LifeCare PCA with Hospira MedNet	20709-04-03
	20709-04-04
	20709-04-51
	20709-04-53
	20709-04-77
	20709-04-78
Nutrimix Micro Compounder	11365-04-01
	11365-04-03
	11365-04-05
Omniflow 4000 Plus	826-85559-003
	826-85559-006
	826-85559-008
	826-85559-010
	826-96057-003
Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer	50132-04-05
Oximetrix 3 SO2/CO Cardiac Output Computer	50130-04-07
Plum LifeCare 5000 (Plum1.6) with dataport	02507-04-01
	02507-04-03
	02507-04-04
	02507-04-05
	02507-04-07
	02507-04-08
	02507-04-09
	02507-04-10
	02507-04-11
	02507-04-12
	02507-13-03
	02507-13-04
	02507-13-05
	02507-13-06
	02507-13-11
	02507-13-12
Plum A+ v.11.X	12391-04-01
	12391-04-02
	12391-04-03
	12391-04-04
	12391-04-05
	12391-04-06
	12391-13-01
	12391-13-02
	12391-13-03
	12391-13-04
Plum A+ v.10.3	11971-04-01
	11971-04-03
	11971-04-05
	11971-04-07
	11971-04-51
Plum A+3  v.11.X	12618-04-01
	12618-04-02
	12618-04-03
	12618-04-04
	12618-04-05
	12618-04-06
	12618-04-51
Plum A+3 Infusion System with Hospira MedNet	20678-04-01
	20678-04-02
	20678-04-81
	20678-04-82
Plum A+ Infusion System with Hospira MedNet	20679-04-03
	20679-04-04
	20792-04-01
	20792-04-02
	20792-04-51
	20792-04-52
	20792-04-81
Plum XL	11555-04-01
	11555-04-04
	11555-13-01
	11555-13-02
Plum XLD	11859-04-01
	11859-04-02
	11859-04-03
	11859-04-04
	11859-04-11
	11859-04-12
Plum XL 3	11781-04-01
	11781-04-03
	11781-04-06
Plum XL3M	11845-04-03
	11845-04-04
	11845-04-05
	11845-04-06
	11845-04-07
	11845-04-08
	11845-04-12
	11845-04-13
	11845-04-14
Plum XLM	11846-04-03
	11846-04-04
	11846-04-06
CO2/CO COMPUTER	52235-04-01
	52235-04-02
Spare Part Inventory (Replacement Cords)	826-85559-003
	826-85559-006
	826-85559-008
	826-85559-010
	826-96057-003

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