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Sorin Centrifugal Pump CP5 System and Control Panel (2017-10-27)
- Starting date:
- October 27, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65082
Affected products
A. SORIN CENTRIFUGAL PUMP CP5 SYSTEM
B. SORIN CENTRIFUGAL PUMP CP5 PUMP CONTROL PANEL
Reason
During internal testing, LivaNova identified a possibility that automatic line closure by The Electrical Remote-Controlled Tubing Clamp (ERC) after detection of an air bubble could take longer than is intended by design in the CP5 system. This could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the IFU (1 meter).
Affected products
A. SORIN CENTRIFUGAL PUMP CP5 SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
60-00-60
Companies
- Manufacturer
-
LIVANOVA DEUTSCHLAND GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY
B. SORIN CENTRIFUGAL PUMP CP5 PUMP CONTROL PANEL
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
60-02-60
Companies
- Manufacturer
-
LIVANOVA DEUTSCHLAND GMBH
LINBERGHSTRASSE 25
MUNICH
80939
GERMANY