BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASBLOOD SECONDARY SET

    MDR report key: 1961680 · Received December 28, 2010

    Report

    Report Number
    9615050-2010-00280
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 1, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    KDC
    PMA / PMN Number
    K780880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DISCONNECTION. THE SECURE LOCK MALE ADAPTER OF THE SECONDARY BLOOD SET WAS CONNECTED TO THE CLAVE Y-SITE OF A PLUMSET TO DELIVER AN UNSPECIFIED BLOOD PRODUCT. IT WAS REPORTED THAT THE COLLAR OF THE SECURE LOCK WAS "STUCK" IN PLACE AND WOULD NOT ROTATE; HOWEVER, THE TUBING SET REMAINED IN CLINICAL USE. REPORTEDLY, A FEW MINUTES AFTER THE NURSE INITIATED THE BLOOD DELIVERY, THE SECURE LOCK MALE ADAPTER OF THE BLOOD SET DISCONNECTED FROM THE DISTAL CLAVE Y-SITE OF THE PLUMSET AND AN UNSPECIFIED VOLUME OF THE BLOOD PRODUCT LEAKED. THE SECONDARY BLOOD SET AND THE UNSPECIFIED BLOOD PRODUCT WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASBLOOD SECONDARY SET 79KDC KDC HOSPIRA COSTA RICA LTD. NA 890165H

    Patients

    Seq Age Sex Outcome Treatment
    1 PLUMSET LIST # 12030, LOT # UNK