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

Model Number 102953

Device Problems Mechanical Problem (1384); Shipping Damage or Problem (1570)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the full report.

Event Description

It was reported that the blood pump was damaged.The account requested a replacement and a return label to return the blood pump.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the centrimag blood pump, lot number l06829-la5 confirmed damage to the packaging; however, a specific cause for the damage could not conclusively be determined through this evaluation.It was reported that the centrimag blood pump, lot number l06829-la5, was damaged.A replacement was requested.No adverse patient events were reported.Multiple attempts to gather additional information was attempted; however, none was provided.The centrimag blood pump, lot number l06829-la5, was returned in the blue carrying case.The left clip used to secure the carrying case closed was missing; however, the right clip appeared to function as intended.Visual inspection of the interior of the blue case revealed a dented area adjacent to the missing clip.The hinge on the rear of the carrying case was broken.Further examination of the interior of the carrying case revealed the packaging containing the centrimag blood pump.The white packaging surrounding the sealed sterile packaging was dented and creased.The sealed sterile packaging was removed and was dented; however, the sterile seal did not appear to be broken.The centrimag blood pump was removed from the sterile packaging.The inlet and outlet ports revealed no evidence of cracking or other damage.The pump housing showed no evidence of abnormal scratching or other damage.The rotor blades revealed no evidence of abrasion or damage.The rotor base showed no evidence of abrasion or other damage.The rotor well revealed no evidence of abnormal scratching or other damage.There was no evidence of separation or slippage between the rotor magnet and rotor body.Microscopic inspection of the blood pump revealed no anomalies.The blood pump was connected to a mock circulatory loop with a test 2nd generation centrimag primary console, motor, flow probe, and tubing circuit using a test pressure transducer.The blood pump was mounted onto the test motor without issue.The blood pump functioned as intended in accordance with manufacturing specification (see attached testing data).The blood pump was operated on the test system and no clicking or other abnormal pump sounds were observed during testing.The device history record was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag vad ifu contains the following caution.Caution #4 states that the pump is provided sterile in an unopened and undamaged unit package and to inspect the device and packaging carefully prior to use.Do not use if the unit package or the product has been dropped, damaged or soiled.This ifu also states under ¿inspection prior to use¿ that the package containing the pump should be inspected prior to use for any damage to the sterile barrier.Do not use the pump if the associated package is damaged.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: 11162722
• MDR Text Key: 234728831
• Report Number: 3003306248-2020-06204
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L06829-LA5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1