MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC RECHARGEABLE LI-ION BATTERY; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-50207

Device Problems Electrical Power Problem (2925); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter full address 1: (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 2916596-2020-04576 and 2916596-2020-04578.It was reported that the patient experienced flows below the minimum.The battery indicator went from fully charged and fell to minimum and the pump speed display dropped to zero suddenly.The system was replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag system fully stopping was not confirmed.The returned centrimag battery (serial number (b)(6) was individually tested and was found to perform as intended.However, due to the battery¿s expiry date, the battery was scrapped.Although an issue was not observed within the centrimag battery, issues that may have contributed to the reported event were identified via the centrimag console¿s and centrimag motor¿s investigations.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag battery, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Section 10, entitled "emergency/trouble shooting" of the centrimag primary console operating manual, states: "the recommended practice whenever there is a 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 back-up motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC RECHARGEABLE LI-ION BATTERY
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 10546360
• MDR Text Key: 207315941
• Report Number: 2916596-2020-04579
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 201-50207
• Device Catalogue Number: 201-50207
• Device Lot Number: 6444147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS; PRIM CONS 1ST GEN, STANDALONE; CENTRIMAG MOTOR, OUS; PRIM CONS 1ST GEN, STANDALONE
• Patient Outcome(s): Required Intervention