BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD SECONDARY SET

    MDR report key: 1702863 · Received May 24, 2010

    Report

    Report Number
    9615050-2010-00097
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DELAY IN CRITICAL THERAPY. A PRIMARY TUBING SET WAS DELIVERING AN UNSPECIFIED VOLUME OF NORMAL SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE BLOOD TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR DELIVERY OF A UNIT OF PACKED RED BLOOD CELLS (PRBCS) TO THE PATIENT WHO WAS UNDERGOING A DIALYSIS TREATMENT. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT AFTER NURSE RAISED THE IV POLE TO AN UNSPECIFIED HEIGHT, THE SPIKE OF THE BLOOD TUBING SET CAME OUT OF THE BLOOD CONTAINER. THE TUBING SET AND THE BLOOD CONTAINER WERE REPLACED AND THE THERAPY WAS RESUMED. THE AMOUNT OF TIME NEEDED TO REPLACE THE TUBING SET AND BLOOD CONTAINER WERE NOT REPORTED. THE CUSTOMER CONTACT INDICATED THAT THE DELAY IN THERAPY WAS REPORTED AS CRITICAL TO THIS PATIENT; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT REPORTED THAT THE NURSE STATED, THE TUBING SET WAS TOO SHORT AND THE SPIKE IS TOO SHORT AND SMALL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD SECONDARY SET 79KDC KDC HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1