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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 UNK-PUMP
Device Problems Increase in Suction (1604); Pumping Problem (3016)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
Event Date 08/04/2020
Event Type  Injury  
Event Description
It was reported that the ventricular assist device (vad) exhibited low flow alarms and suction alarms. The patient received intravenous (iv) fluids and continued to have frequent alarms, dizziness and orthostasis. It was also reported that the controller was programed incorrectly by the site. The controller was reprogramed and is functioning correctly. The vad and controller remain in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation. Product event summary: one (1) pump with an unknown serial number and one (1) controller ((b)(4)) were not returned for evaluation. Log file analysis revealed that the pump id were not set during the initial programming of the controller. The implant date was initially set to (b)(6) 2006 at 18:15:44 in the event log file. Analysis of the event log file also revealed multiple clock change events were logged within the analyzed period. If the pump id is not set when the controller is connected to the monitor, the monitor will automatically set the controller date/time and the implant date to match the current date/time of the monitor. Analysis of the event log file revealed that the time and date was updated by the site on (b)(6) 2020 at 14:44:21 and the pump id was entered by the site on (b)(6) 2020 at 14:08:30. Log file analysis did not reveal any anomalies involving the controller. Additionally, log file analysis revealed 20 low flow alarms and 26 suction alarms were logged within the analyzed period. As a result, the reported low flow, suction and "controller programmed incorrectly by the site" issue events were confirmed. The most likely root cause of the observed patient id and pump id not set in the log files could be attributed to an incorrect set up process. The most likely root cause of the observed clock change events can be attributed to troubleshooting and the controller with no set pump id connected to the monitor, triggering the monitor to update the date/time of the controller and the implant date. Based on the available information, the device may have caused or contributed to the reported low flow and suction event. Based on the risk documentation, possible causes of the low flow and suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed. 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. Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0. Model #: 1420, catalog #: 1420, expiration date: 31-dec-2020, serial#: (b)(4), udi #:(b)(4). Device available for evaluation: no. Device evaluated by mfr: yes. Device manufacture date: 12-dec-2019. Labeled for single use: no. (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
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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 Key14475318
MDR Text Key293443393
Report Number3007042319-2022-05203
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-PUMP
Device Catalogue NumberUNK-PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
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: 05/23/2022 Patient Sequence Number: 1
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