BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 13666223 · Received March 4, 2022

    Report

    Report Number
    3007042319-2022-02812
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    July 23, 2020
    Report Date
    March 4, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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. USER FACILITY: UNKNOWN, USER FACILITY NAME/ADDRESS: UNKNOWN, CONTACT PERSON: UNKNOWN, PHONE NUMBER: UNKNOWN, DATE USER FACILITY BECAME AWARE OF THE EVENT: 13-AUG-2020. TYPE OF REPORT: INJURY, DATE OF THIS REPORT: 13-AUG-2020. APPROXIMATE AGE OF DEVICE: UNKNOWN. EVENT PROBLEM CODES: (B)(4), REPORT SENT TO FDA: 13-AUG-2020. LOCATION WHERE EVENT OCCURRED: CLINIC. REPORT SENT TO MANUFACTURER: UNKNOWN. MANUFACTURER NAME AND ADDRESS MFR. NAME: MEDTRONIC, PLC. ADDL: (B)(6). CITY: (B)(6). ZIP: (B)(6). PRODUCT EVENT SUMMARY: ONE (1) VENTRICULAR ASSIST DEVICE (VAD) WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENT COULD NOT BE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE 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. 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 VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED INTERMITTENT LOW FLOW ALARMS. THE VAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569749 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown