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

Model Number 107758

Device Problem Insufficient Information (3190)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the mobile power unit alarmed continuously.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: the battery ribbon was frayed.The reported event of a continuous alarm from the mobile power unit (mpu) was confirmed.The mpu (serial number: (b)(6)) was returned to the european distribution center (edc), and the reported event was reproduced when the mpu was connected to ac power.The alarm was resolved by replacing the patient cable.No further issues were observed after replacing the patient cable.A full functional checkout was performed after replacing the patient cable and the unit passed all tests.The replaced patient cable was forwarded to product performance engineering (ppe) for further evaluation.The patient cable was tested with a test mpu and the continuous audio alarm was reproduced when the mpu was connected to ac power.No alarm symbols were illuminated on the mpu during the audio alarm.The mpu was connected to a test system controller, which was connected to a mock circulatory loop, and system operated at the set speed without issue; no alarms were active on the system controller.He mpu patient cable was disconnected from the test mpu, and the continuous audio alarm resolved.Further evaluation of the patient cable revealed that the red (alarm), blue (redundant 15v return), and green (redundant 15 v return) wires were shorted to the cable shielding.The alarm wire shorting to the cable shielding and/or the 15v return would result in the observed behavior of an audio alarm when the mpu is connected to ac power.The exact location of where the alarm and redundant 15 v return wires were making contact with the cable shield was not determined.The reported event was determined to be due to the alarm wire shorting to the cable shielding and to the redundant 15v return wires in the mpu patient cable.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.Heartmate 3 patient handbook (rev.G), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.G), under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Furthermore, the subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the mobile power unit patient cable¿ and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate 3 patient handbook (rev.G) section 6 "caring for the equipment" and heartmate 3 ifu (rev.G) section 8 ¿equipment storage and care¿ describe how to care for and clean all equipment.Heartmate 3 patient handbook (rev.G) section 10 and heartmate 3 ifu (rev.G) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.G) 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, 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: 15075122
• MDR Text Key: 296404339
• Report Number: 2916596-2022-12267
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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: 107758
• Device Lot Number: 7792607
• 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: 07/11/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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