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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE GOGEAR SHOWER BAG; VENTRICULAR (ASSIST) BYPASS Back to Search Results
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.
 
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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 Key14567854
MDR Text Key294674967
Report Number2916596-2022-11001
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011149
UDI-Public00813024011149
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160054
Number of Events Reported1
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 Number104232
Device Catalogue Number104232
Device Lot Number8155834
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 Received06/01/2022
Supplement Dates Manufacturer Received05/11/2022
Supplement Dates FDA Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age38 YR
Patient SexFemale
Patient Weight55 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
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