MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90001

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

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 patient was on a centrimag pump as part of veno-arterial ecmo and that there was a fast clicking sound coming from the blood pump area.The pump assembly at the motor was noted to be correct but the vad team decided to change the ecmo circuit including the centrimag pump.

Manufacturer Narrative

D4 (lot number), h5, h8: correction.Manufacturer's investigation conclusion: the report of a fast clicking sound coming from the blood pump could not be confirmed through this evaluation as no video/audio clips of the running centrimag system were submitted for review.No device-related issues were discovered during the evaluation of the returned centrimag blood pump, lot number l06429-la6.No abnormal noises were reproduced during functional testing of the returned blood pump and a specific cause for the reported event could not be conclusively determined.It was reported that the patient was supported on a centrimag blood pump as part of v-a ecmo.On (b)(6) 2020, the nurse reportedly noticed a fast clicking sound coming from the blood pump area.Information provided indicated that the blood pump was found to be properly mounted to the motor; therefore, the vad team decided to exchange the ecmo circuit including the centrimag blood pump.No centrimag system alarms or adverse consequences were reported in association with the event.The centrimag blood pump, lot number l06429-la6, was returned with tubing attached to the inlet and outlet ports with zip ties.Visual inspection of the pump¿s inlet and outlet ports as well as the pump housing showed no evidence of cracking or other damage.Examination of the pump's blood-contacting surfaces revealed no evidence of depositions or thrombus formations.Visual inspection of the blood pump revealed no evidence of abrasion or other damage to the impeller blades or remainder of the rotor and showed no evidence of abnormal scratches on the pump housing or rotor well.There was no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, microscopic inspection of the blood pump revealed no anomalies.The blood pump was functionally tested on a mock circulatory loop with a test motor and equipment.The blood pump functioned as intended in accordance with manufacturing specification.The blood pump was operated on the test system for an extended period of time and no clicking or other abnormal pump sounds were observed during testing, even at the maximum set speed.The device history record was reviewed and showed that the device was manufactured in accordance with manufacturing and quality assurance specifications.The centrimag vad ifu contains the following warnings and cautions: ifu warning #3: back-up components must always be available.Ifu warning #5: integrity of the components in the perfusion system must be carefully and constantly monitored before and during use.Ifu warning #17: frequent patient and device monitoring is recommended.Ifu caution #14: always have a spare centrimag vad, centrimag back-up console and spare equipment readily available for change.The section titled blood pump setup and operation warns the user that if leaks or other anomalies are found on the centrimag vad, remove the blood pump and replace with a new, sterile blood pump.The ifu also contains a section titled emergency blood pump replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• 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: 10124472
• MDR Text Key: 196423279
• Report Number: 2916596-2020-02818
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 7640135140627
• UDI-Public: (01)7640135140627(10)L06429-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: 07/29/2020

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: 04/30/2022
• Device Model Number: 201-90001
• Device Lot Number: L06429-LA6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1