BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDRY SET 34IN NDEHP W/EXT HOOK

    MDR report key: 2860033 · Received December 4, 2012

    Report

    Report Number
    9615050-2012-01457
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE OPTION-LOK MALE ADAPTER OF THE PRIMED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED ANTIBIOTIC. IT WAS REPORTED THAT THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT AFTER THE PIGGYBACK DELIVERY WAS STARTED, NO FLOW OF SOLUTION WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT THE NURSE LOWERED THE PRIMARY SOLUTION CONTAINER FURTHER; HOWEVER, NO FLOW OF SOLUTION WAS AGAIN NOTED. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS DISCONNECTED FROM THE PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET AND RECONNECTED TO PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET. NO FLOW OF SOLUTION WAS AGAIN NOTED. IT WAS REPORTED THE PRIMARY TUBING SET WAS CLAMPED AND THE PUMP ALARMED FOR AN UNSPECIFIED OCCLUSION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE PIGGYBACK SOLUTION FLOWED. THE TUBING SET REMAINED IN CLINICAL USE AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECONDRY SET 34IN NDEHP W/EXT HOOK 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDS SMARTSITE PRIMARY TUBING SET, REF # (B)(4)| MFR CAREFUSION CORPORATION