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

Model Number 102953

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

This event was also reported against the centri mag motor under mfr # 2916596-2019-05860.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The site reported there was a loud noise coming from the centrimag motor.The motor began to rattle loudly after the patient was ambulated.The speed and flow were noted to be 3800 rpms and 5l.The motors temperature was normal.During the event, the patient was hemodynamically stable.The pump and motor were swapped without issue.When the old pump was drained and placed back in the motor, the same noise occurred.There are no additional issues reported and the patient was stable.No further information was provided.

Manufacturer Narrative

Section a2, d4 & h4: additional information manufacturer's investigation conclusion: the report of a loud noise coming from the pump/motor 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.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.Information provided indicated that the centrimag blood pump and motor were switched out without issue.After the old blood pump was drained and placed back in the motor, the same noise reportedly occurred.The noise was reportedly thought to be potentially related to an issue with the blood pump, which was returned for evaluation; however, it was stated that the motor in use at the time of the event would not be returned.The patient remained stable following the exchange with no further issues.The centrimag blood pump, lot number l06310-la1, was returned with approximately 1 inch of 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 only traces of dried blood with no evidence of any tissue-like depositions, thrombus formations, or other abnormal depositions.Visual inspection of the pump rotor did not reveal any evidence of damage or wear.There was no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, visual inspection of the blood pump revealed no evidence of abrasion or other damage to the impeller blades and no evidence of abnormal scratches on the pump housing or rotor well.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 abnormal pump sounds were observed during testing, even at the maximum set speed.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: 9532365
• MDR Text Key: 176977578
• Report Number: 2916596-2019-06152
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR