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

Model Number L107758

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with most recent approval.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 patient cable was loose at the rubber end around the black and white connector of the mobile power unit.It was also noted that the handle was cracked.

Manufacturer Narrative

Section d4: expiration date was inadvertently included in the initial report but is not applicable for this device manufacturer's investigation conclusion: the reported event, of a damaged mpu patient cable and handle, was confirmed when the unit was evaluated by depot services.The rubber boot (overmold) on the mpu patient cable connector block was separating from the connector block around the connectors.The base of the handle was cracked; there no missing pieces or exposed internal components due to the crack.The patient cable connector block was examined and no ingress or damage were found.The overmold did not interfere with the power lead connectors when checked.The patient cable connectors are molded into a hard form block; the block is then overmolded with rubber.The issue with the overmolding was cosmetic and not functional.The damaged sub-assemblies were replaced and the repaired mpu was tested and returned to the rental/loaner pool.The mpu unit was over 6 years old.The root causes of the overmold separation and handle damage were not determined in this analysis.Incidental findings: mpu patient cable discoloration: the outer jacket of the mpu patient cable was discolored.There was a yellowish tone to the cable¿s outer jacket color as compared to reference/new mpu patient cables.The discoloration was throughout the entire length of the outer jacket.The discoloration was not reported in the service report or event description.The mpu assembly was made oct 13, 2016.The mpu unit was packaged and placed into stock on oct 25, 2016.The mpu was last sent to a customer on apr 3, 2019.The unit was returned from use on mar 22, 2022.Set up and use of the mobile power unit (mpu) with the heartmate 3 lvas are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas instructions for use (ifu).Specific warnings and cautions regarding the mpu's set up, the potential tripping hazards presented by the mpu patient cable and power cord, and the electrical outlet used (including location and accessibility) are given in both the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.Replacing the mpu batteries is described in the heartmate 3 lvas patient handbook.Mpu battery inspection and maintenance are described in the monthly safety checklist and six month safety checklists.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 (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: 13357357
• MDR Text Key: 285149443
• Report Number: 2916596-2022-00125
• 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: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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: 183476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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