BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2211647 · Received August 5, 2011

    Report

    Report Number
    1219343-2011-00115
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 18, 2011
    Report Date
    August 5, 2011
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2011 AND ALLEGED THAT AN ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAD A LOUD NOISE FOLLOWED BY A BLOOD SPILL. NO PATIENT INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO HAEMONETICS ON (B)(6), 2011. UPON EVALUATING THE DEVICE FLUID INGRESS WAS FOUND. THE FLUID INGRESS RESULTED IN DAMAGE TO ELECTRONIC COMPONENTS. IT WAS UNCONFIRMED WHETHER SPILL BAGS WERE DEPLOYED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2011 AND ALLEGED THAT AN ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAD A LOUD NOISE FOLLOWED BY A BLOOD SPILL. NO PATIENT INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI