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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
Patient Problems Dehydration (1807); Hemolysis (1886); Pleural Effusion (2010)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
Product event summary: hw41264 was not returned for evaluation. This complaint is associated with a clinical adverse event. Information provided by the site indicated that the patient experienced hemolysis. Additional information indicated that the patient had elevated lactate dehydrogenase (ldh) and the patient¿s hemoglobin (hgb) was risen sharply. A bone biopsy was performed and it was stated that the patient might have hemophagocytic syndrome. Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event. Per the instructions for use, hemolysis is a known potential complication associated with the implantation of a vad. There was no evidence that the patient had a history of similar adverse events. Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course. There are possible patient, pharmacological and procedural factors that may have contributed to this event. This regulatory report is being submitted as part of a retrospective review and remediation per d00595827 due to an fda audit observation. 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
It was reported that the ventricular assist device (vad) patient experienced hemolysis. It was stated that there was no observation of sucking that cause hemolysis. The cause of hemolysis is unclear. The vad remains in use. No further patient complications have been reported as a result of this event. It was further reported that the patient had elevated lactate dehydrogenase (ldh) and the patient¿s hemoglobin (hgb) was risen sharply. A bone biopsy was performed and it was stated that the patient might have hemophagocytic syndrome.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSISST) 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 Key13442302
MDR Text Key289257837
Report Number3007042319-2022-00549
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/03/2022 Patient Sequence Number: 1
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