BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 3023244 · Received February 27, 2013

    Report

    Report Number
    1219343-2013-00018
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K992723
    Removal / Correction Number
    1219343-04/29/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. WHEN THE DEVICE WAS INITIALLY POWERED ON SMOKE EMITTED FROM THE DEVICE AND A FUSE SUBSEQUENTLY BLEW. FLUID INGRESS WAS THEN FOUND INTERNAL TO THE DEVICE. THE POWER SUPPLY AND FUSE WERE REPLACED. THE DEVICE WAS UPGRADED TO THE CURRENT FLUID INGRESS REMEDIATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2012, TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "RED CELL PRODUCT WAS VERY DILUTED AND RED CALLS WERE SPILLING INTO WASTE BAG." NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85329 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1