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

Model Number L103868

Device Problem Failure to Charge (1085)

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

Event Date 04/27/2022

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 the internal battery of the power module was defective.The battery could no longer hold a charge and showed a red alarm, although it was constantly powered.The ventricular assist device (vad) coordinator used another power module and system monitor.There was a yellow wrench and a battery hazard symbol in red.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a charging issue and red battery light alarm on the power module was confirmed.(b)(6) was evaluated by the european distribution center (edc) where the event was reproduced.The unit came in with a damaged battery clip, cracked rubber feet, and damaged vent bands.The battery clip had a bent contact that would not make a secure connection when connected to the battery.The system booted up as intended and passed the functional test after the battery clip was replaced.Preventive maintenance was performed and the unit was returned to the rental pool.The root cause for the reported event was due to a damaged battery clip that was not making consistent contact with the battery.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.(b)(6) was shipped to the customer.The patient handbook cautions the 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.Heartmate 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot atypical alarms.Heartmate 3 instructions for use section 3-¿powering the system¿ states that the power module contains an internal backup battery that provides approximately 30 minutes of backup power to the system during a power emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE POWER MODULE, EU
• Type of Device: VENTRICULAR (ASSIST) 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: 14240684
• MDR Text Key: 290535021
• Report Number: 2916596-2022-10677
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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: L103868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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