MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the perfusionist team was unable to fit the blood pump into the motor.The blood pump was correctly placed in the motor but it was not possible to turn the blood pump to secure it.The blood pump was exchanged.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of the centrimag blood pump not being able to fit in the motor could not be confirmed based on the evaluation of the returned blood pump.It was reported on (b)(6) 2020 that the perfusionist team was unable to fit the blood pump properly in the centrimag motor.Per the report, the pump was placed in the motor with the grooves matching the notches but then it was impossible to turn the pump to secure it.The decision was made to replace the pump with another one.The centrimag blood pump, lot number l06567-la6, was returned to abbott manufacturing personnel in zurich, switzerland for evaluation.Visual inspection of the returned blood pump revealed no evidence of atypical depositions.The pump housing was intact; however, examination of the blood pump revealed areas of damage on the circumference of the pump housing near the locking grooves that appeared consistent with abrasion.The blood pump was able to be successfully mounted onto multiple test motors when an adequate mounting torque was applied.Of note, the motor in use at the time of the reported event was not returned for evaluation.A specific cause for the reported event could not be conclusively determined through this evaluation.A device history record (dhr) review did not identify any product manufacturing related issues or non-conformances.Although the investigation did not confirm the reported event and determined that the blood pump met the current established specifications, a capa was initiated to further investigate the current inspection process/specifications.The centrimag ventricular assist device (vad) instructions for use (ifu) provides instructions for how to mount the blood pump on the motor.This document additionally states to always have a backup centrimag system available for use.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump l06567-la6) revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 10173166
• MDR Text Key: 198188061
• Report Number: 3003306248-2020-00050
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 7640135140030
• UDI-Public: (01)7640135140030(10)L06567-LA6
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: 201-90010
• Device Lot Number: L06567-LA6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1