IntelliVue -Information Centre iX - Software, IntelliBridge System (2019-05-05)

Starting date:

May 5, 2019

Posting date:

May 17, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69972

Last updated: 2019-05-17

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  Reason
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  Affected products

Affected Products

A. IntelliVue -Information Centre iX - Software

B. IntelliBridge System

Reason

Data from the B. Braun Space LAN or arcomed UniQueDOC infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patient's chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values. Only the HL7 output from the Patient Information Center iX is affected. This problem only happens when the PIC iX or IBS is configured for regional settings in which a comma is used as the decimal separator.

For example, a pump delivering medication at 5.00 cc shows 500.00 cc in the patient's chart or electronic medical record (EMR).

Affected products