BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIMAG BLOOD PUMP

    MDR report key: 19522623 · Received June 12, 2024

    Report

    Report Number
    3003306248-2024-02757
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 12, 2024
    Report Date
    August 27, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    PMA / PMN Number
    K090051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF THE PEDIVAS BLOOD PUMP STOPPING SUDDENLY COULD NOT BE CONFIRMED THROUGH THIS EVALUATION, AS NO LOG FILES WERE SUBMITTED FOR REVIEW. A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. THE PEDIVAS BLOOD PUMP WAS NOT RETURNED FOR EVALUATION. A LOT NUMBER OF THE PEDIVAS BLOOD PUMP WAS REPORTED; HOWEVER, IT WAS NOT VALID. A VALID LOT NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE OUTSIDE UNITED STATES (OUS) PEDIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU), REV A IS CURRENTLY AVAILABLE AND CONTAINS THE FOLLOWING ADDITIONAL WARNINGS AND CAUTIONS: IFU WARNING #10: POTENTIAL RISK TO THE PATIENT SHOULD BE EVALUATED PRIOR TO CHANGING A PEDIVAS BLOOD PUMP. IFU WARNING #11: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #15: ALWAYS HAVE A SPARE BLOOD PUMP, BACK-UP CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR CHANGE OUT. THE SECTION TITLED ¿EMERGENCY BACK-UP EQUIPMENT¿ STATES THAT A STERILE BACK-UP BLOOD PUMP CIRCUIT AND PRIMING ACCESSORIES MUST BE AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ON A PEDIVAS SYSTEM AND THE BLOOD PUMP STOPPED WITHOUT ANY WARNING ALARMS. THERE WAS NO MAGNETIC PULL FROM THE MOTOR AND THE FLOWS WENT TO ZERO. THE PUMP WAS EXCHANGED WITH THE BACKUP MOTOR AND FLOWS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153165 PEDIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 201-90052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female