FDA MedWatch - Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

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Title: FDA MedWatch - Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump

Models CS100i, CSO100, CS300

AUDIENCE: Risk Manager, Cardiology, Surgery

ISSUE: Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.

• Lot Numbers: All Lots Manufactured July 1, 2003 to June 16, 2017
• Manufacturing Dates: July 1, 2003 to June 16, 2017
• Distribution Dates: March 24, 2003 to June 16, 2017
• Devices Recalled in the U.S.: 5,049

BACKGROUND: Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.

RECOMMENDATIONS: On July 17, 2017, Datascope Corp./MAQUET sent affected customers an "Urgent Product Recall Medical Device Field Correction" notice informing them of the device's risks, and listing actions that should be taken to minimize the risk of patient harm until affected IABP units can be serviced. The firm recommends that the risks and benefits of using an affected CS100i, CS100, or CS300 IABP be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available.

The notice asked customers to please adhere to the following instructions:

• Check inventory to identify any affected IABP units that may be stored or are currently in use.
• Pursuant to the User Instruction Warnings, health care providers are instructed not to leave a patient unattended during IABP therapy.
• Be aware that customers with affected IABP unit(s) will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service to install gaskets in the IABP unit(s) and upgrade software.
• Until the affected unit is serviced for the potential false blood detection alarm, clinicians should follow the instructions on the Blood Detection Alarm Help Screen to validate or clear the alarms.
  • Maquet/Getinge recommends that users review the water condensation procedure to reduce the potential for condensation accumulation.
  • In the event the IABP fails to successfully cycle and clear the alarm, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office.
• Until the affected unit is serviced for the potential fluid ingression into the IABP, users should review the operating instructions regarding cautions on placement of fluids and hanging of bags of fluid over the IABP.
• Customers are instructed to complete and return the Medical Device Field Correction Response Form enclosed in the notice via fax to 1-973-807-9217, or email at: IABP2017TWO@xxxxxxxxxxx.
  • If you are a distributor who has shipped any affected products to customers, please forward the Urgent Product Recall Medical Device Field Correction Notice to their attention for appropriate action.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574893.htm

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