BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 3964174 · Received May 28, 2014

    Report

    Report Number
    9615050-2014-03674
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 BREAKAGE OF THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER. THE TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF AN EXTENSION TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION, AT AN UNSPECIFIED RATE, VIA A SYMBIQ PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE WENT TO CHECK ON THE PATIENT. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE NOTED THAT THE PATIENT'S BLOOD HAD BACKED UP THE EXTENSION SET AND AN UNSPECIFIED VOLUME OF THE PATIENT'S BLOOD AND AN UNSPECIFIED VOLUME OF SOLUTION LEAKED ONTO THE PATIENT'S BEDDING. IT WAS REPORTED THAT THE DISTAL TIP OF THE OPTION-LOK MALE ADAPTER HAD BROKEN IN HALF AND A PIECE REMAINED LODGED INSIDE THE FEMALE ADAPTER OF THE EXTENSION SET. THE PRIMARY TUBING SET AND THE EXTENSION SET TUBING WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314700 PRIM SYM SET 2 CL 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR DUAL CHANNEL SYMBIQ PUMP: LIST#16027, SN (B)(4)| EXTENSION SET: LIST #12678, LOT #UNK