BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY CP CENTRIFUGAL PUMP

    MDR report key: 7581572 · Received June 8, 2018

    Report

    Report Number
    2184009-2018-00013
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    January 1, 2018
    Report Date
    July 18, 2018
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWE
    PMA / PMN Number
    K080824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO DEFINITIVE CONCLUSIONS CAN BE MADE REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION; BRAND NAME: AFFINITY CP CENTRIFUGAL PUMP. PRODUCT CODE: DWE, MODEL: CBAP40, LOT#: UNKNOWN, UDI: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THAT THIS CENTRIFUGAL PUMP DECOUPLED. THE CUSTOMER STATED THAT THE RPMS EXCEEDED 4000 DURING LONG TERM USE. CUSTOMER STATED THEY WERE AWARE THAT THE IFUS RECOMMEND FLOW OF 4000 RPMS AND BELOW, BUT IN THIS SITUATIONS, THE PATIENT REQUIRED A HIGHER RPM DUE TO A COMBINATION OF SIZE AND METABOLIC DEMAND, IN CONJUNCTION WITH A SMALL CANNULA SIZE. CUSTOMER REPORTED NOTICING THE BLOOD PRESSURE WAS DROPPING AND THE FLOW WAS DIMINISHED. THE BIO-CONSOLE HANDCRANK WAS USED AND FORWARD FLOW WAS ACHIEVED. THE BIO-CONSOLE INSTRUMENT WAS CHANGED OUT WITH A BACKUP. THE RPM WAS TURNED UP TO 4200 USING THE SAME CENTRIFUGAL PUMP AND THE SITUATION REPEATED. THE HANDCRANK WAS USED AGAIN, THE CENTRIFUGAL PUMP WAS REPLACED AND BLOOD FLOW RE-ESTABLISHED. RPMS WERE KEPT UNDER 4000 AND NO FURTHER ISSUES WERE NOTED. THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424835 AFFINITY CP CENTRIFUGAL PUMP TUBING, PUMP, CARDIOPULMONARY BYPASS DWE PERFUSION SYSTEMS CBAP40 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention