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

Model Number 107754

Device Problems Fracture (1260); Mechanical Problem (1384); Complete Loss of Power (4015)

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

Event Date 03/14/2022

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 patient's mobile power unit (mpu) cracked where the v-lock connection is made.The patient was connected to the mpu when it became disconnected, received a critical alarm due to power loss, and was running on the backup battery for about 5 minutes.The power cable was no longer secured.The mpu was pulled out of service and the patient used batteries.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the ¿ac power inlet was damaged¿ was confirmed with the submitted photos of mobile power unit (serial (b)(6).The submitted reference photos captured a piece missing from the a/c cord receptacle.It was noted to be the location of where the locking tab on the a/c power cord is secured.A root cause of the damaged a/c cord receptacle could not be determined during the evaluation.Repair and preventative maintenance were performed.Performed all tests as per procedure, which passed all testing.The mobile power unit was returned to the customer site.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Mobile power unit (serial (b)(6) was shipped to the customer on 19apr2021.Heartmate ii lvas ifu (section 7), heartmate ii (section 5), under alarms and troubleshooting, describes all alarms (visual and audible) and what action should be performed when they do occur.Heartmate ii lvas ifu, heartmate ii patient handbook both of which 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• 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: 13978642
• MDR Text Key: 289889521
• Report Number: 2916596-2022-01701
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 88 KG