MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE GOGEAR SHOWER BAG; VENTRICULAR (ASSIST) BYPASS

Model Number 104232

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was reported that the patient's gogear shower bag had fluid ingress.This shower bag was being used because the patient's other shower bag also had fluid ingress.Related mfr #: 2916596-2022-11000.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of fluid ingress in the gogear shower bag was not confirmed as no fluid ingress was observed in the bag and the issue was not reproduced during testing.Visual inspection of the returned gogear shower bag (lot number: 8155834) revealed that it was in lightly used condition.The external portion of the shower bag was in unremarkable physical condition.No damage or wear to any of the seams, zippers, or fabrics that could have contributed to a potential leak was observed.Inspection of the interior of the bag did not reveal any areas of water damage or wear to the fabric.The shower bag was mounted in a sink and sprayed with water for over 15 minutes, to simulate the bag being used in the shower.Following the test, no water was observed inside the shower bag, and the interior surfaces of the bag did not feel wet to the touch.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate gogear shower bag, lot number 8155834, was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 instructions for use (ifu) (rev.A) and patient handbook (rev.C) state in the caring for wear and carry accessories sections that wear and carry accessories should be periodically inspected for damage or wear.If an accessory appears damaged or worn, do not use it.Call your hospital contact for a replacement.The ifu explains that although the external components of the heartmate 3 left ventricular assist system (lvas) (including the shower bag) are moisture-resistant, they are not waterproof.The ifu warns that the shower bag must dry completely between uses.After showering, the exterior should be wiped with a clean, dry towel and the bag should be allowed to drip dry completely before being used again.The ifu and patient handbook also provide instructions on using and assembling the shower bag.The patient handbook and the instructions for use caution the user 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 GOGEAR SHOWER BAG
• 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: 14567854
• MDR Text Key: 294674967
• Report Number: 2916596-2022-11001
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: 00813024011149
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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: Lay User/Patient
• Device Model Number: 104232
• Device Catalogue Number: 104232
• Device Lot Number: 8155834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian