BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3952754 · Received May 19, 2014

    Report

    Report Number
    9615050-2014-03488
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 22, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER LOT NUMBER OF THE DEVICE WERE IN USE ARE UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED THE DEVICE AS AN UNSPECIFIED PLUMSET. 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 BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. A PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AT AN UNSPECIFIED TIE, THE OPTION-LOK MALE ADAPTER OF A SECOND UNSPECIFIED TUBING SET WAS CONNECTED TO AN UNSPECIFIED CLAVE SITE ON THE PRIMARY PLUMSET FOR THE PIGGYBACK DELIVERY OF AN UNSPECIFIED VOLUME OF MAGNESIUM. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PLUM PUMP ALARMED FOR DISTAL OCCLUSION. THE CUSTOMER CONTACT REPORTED THAT THE NURSE RESPONDED TO THE ALARM AND FLUSHED THE LINE AT THE Y-SITE; HOWEVER, IT WAS REPORTED THAT THERE WAS RESISTANCE. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE NURSE DISCONNECTED THE OPTION-LOK MALE ADAPTER FROM THE CLAVE SITE AND NOTED THE TIP OF THE OPTON-LOK MALE ADAPTER HAD BROKE OFF. NO SPECIFIC DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE REPORTED ADVERSE PATIENT EFFECTS AND NO REPORT OF DELAY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296177 UNK UNK FPA HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IML UNSPECIFIED PRIMARY PLUMSET, LIST #UNK, LOT #UNK