BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 14207438 · Received April 26, 2022

    Report

    Report Number
    3007042319-2022-04826
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    June 8, 2021
    Report Date
    April 26, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: THE VENTRICULAR ASSIST DEVICE (VAD) WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. LOG FILE ANALYSIS REVEALED INTERMITTENT SUCTION EVENTS LEADING UP TO (B)(6) 2021. HOWEVER, NO ALARMS WERE LOGGED. AS A RESULT, THE REPORTED SUCTION/LOW FLOW EVENT WAS CONFIRMED. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT COULD "FEEL" THE VENTRICULAR ASSIST DEVICE (VAD) WORKING HARDER AT TIMES. IT WAS REPORTED THAT HE PATIENT WAS HAVING BIG SWINGS IN FLOW THAT THEY COULD FEEL LOWER FLOWS. IT WAS ALSO NOTED THAT THERE WAS SUSPICION FOR SUCTION, WHICH COULD CAUSE THE LOW FLOWS THE PATIENT WAS NOTING. UPON ASSESSMENT THE PATIENT WAS DRY AND DIURETICS WERE HELD WHICH WOULD ALSO ADDRESS THE SUCTION. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED SUCTION/LOW FLOW 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. PER THE INSTRUCT IONS FOR USE, PAIN 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COULD "FEEL" THE VENTRICULAR ASSIST DEVICE (VAD) WORKING HARDER AT TIMES. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING BIG SWINGS IN FLOW AND THAT THEY COULD FEEL LOWER FLOWS. ADDITIONALLY THERE WAS SUSPICION FOR SUCTION, WHICH COULD CAUSE THE LOW FLOWS THE PATIENT WAS NOTING. UPON ASSESSMENT THE PATIENT WAS DRY AND DIURETICS WERE HELD WHICH WOULD ALSO ADDRESS THE SUCTION. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206617 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 Male