BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP

    MDR report key: 12702987 · Received October 27, 2021

    Report

    Report Number
    8010762-2021-00574
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 27, 2021
    Manufacturer
    JULIA KAPFENBERGER
    Product Code
    KFM
    PMA / PMN Number
    K080470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT CREATION OF THE ECLS (EXTRA CORPOREAL LIFE SUPPORT) WAS AT 9:25 AM UNDER RESUSCITATION CONDITIONS. AFTER APPROX. 3 HOURS OF RUNNING THE ECLS WHEN "SIG ALARM" OCCURS, THE LPM (LITERS PER MINUTE) COULD NO LONGER BE DISPLAYED. RPM (ROTATIONS PER MINUTE 3600-3800) ARE STILL DISPLAYED AS STABLE. FOR THE UPCOMING RE-CANNULATION, THE ECLS WAS REDUCED TO 1800 RPM, THEN DISCONNECTED AND SHUT DOWN TO 0 LPM. WHEN REMOVING THE DISPOSABLE CENTRIFUGAL PUMP TO RENEW THE CONTACT GEL, FREE BLOOD WAS FOUND UNDER THE CENTRIFUGAL PUMP AND IN THE FLOW MEASURING CHAMBER. CHANGE OF THE ECLS AND THE SYSTEM. NO HARM TO ANY PERSON WAS REPORTED. THE AFFECTED PRODUCT WAS INVESTIGATED AT THE LABORATORY OF THE MANUFACTURER. NO DAMAGES OR ABNORMALITIES WERE DETECTED DURING VISUAL INSPECTION OF THE PRODUCT. DURING A FUNCTIONALITY TEST THE CENTRIFUGAL PUMP WAS OPERATING ACCORDING TO SPECIFICATIONS. NO LEAKAGE WAS DETECTED. THUS THE REPORTED FAILURE "LEAKAGE OF BLOOD UNDER THE CENTRIFUGAL PUMP" WAS NOT CONFIRMED. THE EXACT ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. HOWEVER, AT THE CONNECTION OF THE TUBING TO THE RF-32 BLOOD INLET CONNECTOR BLOOD RESIDUES WERE DETECTED. AS THE RF-32 CENTRIFUGAL PUMP WAS USED BY THE CUSTOMER TOGETHER WITH AN EUROSETS TUBING SET (WHICH IS NOT MANUFACTURED BY MCP) A MOST PROBABLE CAUSE OF THE REPORTED EVENT COULD HAVE BEEN A BLOOD LEAKAGE AT THE EUROSETS TUBING SET CONNECTION TO THE RF-32 CENTRIFUGAL PUMP CAUSED BY TOO LOOSE / DAMAGED CONNECTION. ACCORDING TO THE IFU G-018 V6 SECTION 5.2 THE FOLLOWING MEASURES SHOULD BE FOLLOWED: INSTABLE AND INCORRECTLY CONNECTED COMPONENTS CAN LEAD TO BLOOD LOSS AND AIR EMBOLISMS IN THE PATIENT. USE THE CORRECT TUBE SIZES FOR THE COMPONENTS. CHECK THAT ALL THE COMPONENTS AND DEVICES ATTACHED ARE SECURELY CONNECTED. FIX ALL THE DEVICES USED SECURELY. THE OCCURRENCE RATE REGARDING THE ABOVE COMPLAINT IS BELOW THE ACCEPTANCE RATE. THUS, NO REMEDIAL ACTION REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING. PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE MANUFACTURER IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CREATION OF THE ECLS (EXTRA CORPOREAL LIFE SUPPORT) WAS AT 9:25 AM UNDER RESUSCITATION CONDITIONS. AFTER APPROX. 3 HOURS OF RUNNING THE ECLS WHEN "SIG ALARM" OCCURS, THE LPM (LITERS PER MINUTE) COULD NO LONGER BE DISPLAYED. RPM (ROTATIONS PER MINUTE 3600-3800) ARE STILL DISPLAYED AS STABLE. FOR THE UPCOMING RE-CANNULATION, THE ECLS WAS REDUCED TO 1800 RPM, THEN DISCONNECTED AND SHUT DOWN TO 0 LPM. WHEN REMOVING THE DISPOSABLE CENTRIFUGAL PUMP TO RENEW THE CONTACT GEL, FREE BLOOD WAS FOUND UNDER THE CENTRIFUGAL PUMP AND IN THE FLOW MEASURING CHAMBER. CHANGE OF THE ECLS AND THE SYSTEM. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604126 ROTAFLOW CENTRIFUGAL PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM RF-32 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male