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

Model Number L102956

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

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 a centrimag motor had a damaged locking ring and needed to be replaced.The motor was being sent in for repair.

Manufacturer Narrative

Section a: no patient was involved with the event.Manufacturer's investigation conclusion: incidental findings: damaged connector cap, damaged motor cable.The reported event of damage to the locking ring was confirmed.The centrimag motor (serial#: (b)(6) was returned for analysis and the damaged locking ring was confirmed.The motor was not connected to a centrimag mock loop due to the damaged locking ring.The motor was forwarded to the service depot.The motor was evaluated and tested.The reported event was able to be verified.The locking ring was replaced.The motor was tested with a test console and flow probe and functioned as intended.No alarms or issues were observed during testing.A full functional checkout was performed, and the unit passed all tests.The motor was returned to the rental pool.The motor was retrieved from the rental pool and was returned to abbott.The motor was subsequently scrapped.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag motor (serial#: (b)(6) and the motor was found to pass all manufacturing tests and qa specifications prior to being shipped to the customer.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing this event.

• Brand Name: RENTAL, CENTRIMAG MOTOR
• 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: 10088007
• MDR Text Key: 192046556
• Report Number: 2916596-2020-02554
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

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 Model Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1