MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE, EU; VENTRICULAR (ASSISST) BYPASS

Model Number 103868

Device Problem Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event, of the power module not communicating with the system monitor, was confirmed when the unit was evaluated by technical service.Intermittent loss of display data was observed when the unit was operationally tested.The power module was repaired by replacing the pm pcb assembly (pm board); the repaired unit was tested and returned to the rental/loaner pool.The removed pm board was operationally checked on the test bench with a reference power module.The reported loss of communication between the controller, power module and system monitor was not observed or duplicated.The data from the controller was displayed on the system monitor (via the power module).The system monitor was able to change lvad (pump) parameters.No communication issues were observed on the returned pm board.The root cause of the event was unable to determined based on the evaluation of the pm board.The power module assembly was built in sep 2009.The top assembly was packaged and placed into inventory on sep 29, 2009.The unit was placed into the rental/loaner pool on (b)(6) 2009.The unit was last returned from a customer on apr 1, 2019.The unit was sent to the customer on (b)(6) 2019.The pm pcb assembly (pm board) was installed when unit was built.Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu) p.18 - setting up the system monitor for use with the power module), heartmate 3 left ventricular assist system (lvas) ifu p.4-3 - system monitor) and heartmate ii lvas ifu p.4-3 ¿ system monitor).Power module alarms are addressed in the heartmate 3 lvas ifu and the heartmate power module instructions for use.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the power module was not able to connect with a system controller.No additional information was provided.

• Brand Name: HEARTMATE POWER MODULE, EU
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 11733025
• MDR Text Key: 247708799
• Report Number: 2916596-2021-02335
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 00813024010654
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

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: 103868
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1