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

Model Number L107758

Device Problems Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: incidental findings: discolored patient cable the reported event of a loose rubber connector on the patient cable as well as a damaged thread on the white and black connector was confirmed via visual analysis of the returned unit.The heartmate mobile power unit (mpu) (serial number (b)(4) was returned and evaluated at the european distribution center.During the evaluation, the heartmate mobile power unit, serial number (b)(4) was observed and the rubber encasing of the patient cable was observed to be loose as well as damaged threads on both connectors.A power on/off inspection was completed, and the system booted up as intended.Throughout testing, the system functioned as intended; however, it was difficult to connect the back and white connectors to a test controller.The patient cable was replaced, and preventative maintenance was performed on the unit.The system underwent a full functional checkout and passed all steps without issue.The unit functioned as intended with the exception of increased difficulty connecting both white and black power cables to the test controller.The device history records were reviewed and the records revealed the heartmate mobile power unit (serial#: (b)(4) was manufactured in accordance with manufacturing and qa specifications.(b)(4) was shipped from abbott on 02dec2019.Heartmate ii patient handbook under section 6 ¿caring for the equipment¿ describes how to care for all equipment, including the power module patient cable.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including inspecting the patient cable and connectors.Heartmate ii instructions for use under section 8 ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use, including the patient cable.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution 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.

Event Description

It was reported that patient cable's rubber was loose around black connector.The patient cable had a damaged thread on the black connector making it very difficult to connect.Also, the white connector was very difficult to connect.

• 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: 14745084
• MDR Text Key: 297885634
• Report Number: 2916596-2022-11412
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 06/20/2022

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: L107758
• Device Lot Number: 7282864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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