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

Model Number 1340

Device Problem No Display/Image (1183)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the power module was connected to the patient and the display screen went black.The power module was alarming.The patient was switched to battery power and the power module was swapped out.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of an alarm sounding from the power module, and the power module causing the system monitor to go blank were not confirmed.The reported event of the power module¿s ac power cord having bent metal prongs was confirmed, as the prongs were observed to have been slightly bent upon arrival.The power module (serial number (b)(6) was received by the service depot.The unit was tested alongside all returned equipment and was found to perform as intended, and the bent metal prongs on the ac power cord did not prevent it from connecting to an outlet.The power cord was also manipulated during testing, and no atypical events were reproduced.A full functional checkout was performed, and the serviced and tested power module was returned to the customer site after passing all tests per procedure, alongside a new ac power cord.The root causes of the reported events were unable to be determined through this analysis.The heartmate power module instructions for use (ifu) (rev.B) instructs users to regularly inspect the power module, and to not use a power module that appears damaged.The heartmate power module ifu (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.The heartmate 3 instructions for use (rev.C, section 7 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their power module.The heartmate 3 patient handbook (rev.C, section titled ¿emergency contact list¿) cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Review of the device history record for the power module, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The power module was shipped to the customer on 12sep2012.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE POWER MODULE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12392754
• MDR Text Key: 268966767
• Report Number: 2916596-2021-04488
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 00813024010654
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 60