BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 6125047 · Received November 23, 2016

    Report

    Report Number
    1219343-2016-00086
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 28, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    GKT
    PMA / PMN Number
    BK060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED THAT THE PUMP ROTOR WAS NOT INSTALLED PROPERLY AT THE COMPLETION OF THE PREVENTATIVE MAINTENANCE BY THE HAEMONETICS FIELD SERVICE ENGINEER. THE ENGINEER MOUNTED THE PUMP ROTOR ONTO THE AC PUMP IN AN INCORRECT POSITION. THE FSE HAS BEEN RETRAINED ON THIS MATTER BASED ON THE HAEMONETICS PCS² SERVICE MANUAL.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(6) 2016 ON THE PCS2 PLASMA COLLECTION SYSTEM. THE CUSTOMER REPORTED THAT AFTER PREVENTATIVE MAINTENANCE WAS COMPLETED BY A HAEMONETICS FIELD SERVICE ENGINEER, A PLASMAPHERESIS PROCEDURE WAS RUN ON THE DEVICE. AFTER 550ML OF PLASMA WAS COLLECTED, THE DEVICE SENT A HIGH RETURN PRESSURE ALARM, AND THE PROCEDURE WAS STOPPED. THE CUSTOMER OBSERVED COAGULATION IN THE HARNESS SET AND IN THE NEEDLE. ONE THIRD OF THE BOWL WAS FILLED AND NOT RETURNED TO THE DONOR. THE CITRATE PUMP WAS TURNING, BUT IT DID NOT ADD ANY CITRATE TO THE BLOOD, BECAUSE IT WAS NOT SCREWED IN PROPERLY FROM THE PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777029 PCS®2 PLASMA COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT HAEMONETICS CORP 06002-CP-220-EW

    Patients

    Seq Age Sex Outcome Treatment
    1