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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK VENTRICULAR (ASSIST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 2050
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
A supplemental report is being submitted for device evaluation product event summary: the waist pack was returned for evaluation. Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event. Failure analysis of the returned waist pack revealed that the controller pocket had a torn seam, the fabric of one of the battery pockets was damaged, and the strap loop seam of one of the battery pockets was torn. As a result the reported event was confirmed. The most likely root cause of the waist pack damage can be attributed, but not limited, to wear and/or the handling of the pack. Investigation of this event is completed, and the file will be closed. If new information is received, the file will be re-opened, and a supplemental will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The waist pack was returned to the manufacturer because it was damaged at different areas. The waist pack subsequently tested out of specification during manufacturer¿s ###.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10043729
MDR Text Key190547661
Report Number3007042319-2020-03134
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model Number2050
Device Catalogue Number2050
Device Lot Number1540652
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/11/2020 Patient Sequence Number: 1
Treatment
UNKNOWN VAD
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