CS 300 Intra-Aortic Balloon Pump

FDA device recall Z-2738-2017 · posted 2017-06-23 · Terminated

Recall details

Recalling firm

Maquet Datascope Corp - Cardiac Assist Division

Reason for recall

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Action taken

Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the event the IABP fails to successfully complete the self-test and exhibits electrical test failure code 58, please remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. Customers will be instructed to complete and return the attached Medical Device Field Correction Response Form via fax to 1-973-807-9217 or send via email to IABP2017@getinge.com.ABP2017@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. For U.S. customers with technical questions, please contact our Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST

Root cause

Component design/selection

Status

Terminated

Product code

DSP

Quantity affected

12,319 units total

Distribution

Worldwide Distribution - (in over 100 countries) US (Nationwide)

Date initiated

2017-06-16

Date posted

2017-06-23

Date terminated

2019-11-29

Location

Mahwah, NJ

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