BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 6116805 · Received November 21, 2016

    Report

    Report Number
    1219343-2016-00082
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    GKT
    PMA / PMN Number
    BK920039
    Removal / Correction Number
    B-0349-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAEMOENTICS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THE ROTORS WERE TESTED WITH A DUROMETER AND THEY WERE WITHIN SPECIFICATION. THE FSE REPLACED THE ROTORS FOR PRECAUTIONARY MEASURES. THE NEW ROTORS WERE REPLACED AND THE MACHINE PUT BACK IN SERVICE. NO ROOT CAUSE OF THE ANTICOAGULANT DEPLETION WAS FOUND. THIS ISSUE OF ANTICOAGULANT DEPLETION HAS BEEN INVESTIGATED UNDER A CORRECTIVE ACTION. THE RESULTS OF THAT INVESTIGATION DETERMINED THE LIKELY CAUSE WAS THE HARSH CLEANING SOLUTION USED TO CLEAN THE PUMP ROLLERS AT THE CUSTOMER SITE CAN CAUSE DAMAGE TO THE PUMP ROLLERS WHICH MAY LEAD TO A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(6) 2016 FOR A REPORT OF ANTICOAGULNAT (AC) DEPLETION WITH NO DONOR REACTION. THE CONSUMPTION OF AC WAS HIGHER THAN EXPECTED (ON THE FINAL SCREEN IT WAS MENTIONED 130ML USED BUT THE BAG WAS NEARLY EMPTY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769372 PCS®2 PLASMA COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC, GKT HAEMONETICS CORP 06002-CP-220

    Patients

    Seq Age Sex Outcome Treatment
    1