BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 6099389 · Received November 14, 2016

    Report

    Report Number
    1219343-2016-00078
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS HAS REQUESTED THAT THE ROTORS BE RETURNED FOR EVALUATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THE REQUESTS. THIS ISSUE OF ANTICOAGULANT (AC) 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. NEW ROTORS WERE SENT TO THE CUSTOMER FOR THE ON-SITE TECHNICIAN TO REPLACE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON 10/17/2016 FOR A REPORT OF ANTICOAGULANT (AC) DEPLETION NO DONOR REACTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750006 PCS®2 PLASMA COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC,, GKT HAEMONETICS CORP 06002-CP-110

    Patients

    Seq Age Sex Outcome Treatment
    1