BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC 5000 DUAL CHAMBER PUMPSET

    MDR report key: 1659280 · Received April 13, 2010

    Report

    Report Number
    9615050-2010-00069
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 17, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K052052. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 A DISCONNECTION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AT AN UNSPECIFIED TIME, AN UNSPECIFIED CLAVE PORT WAS CONNECTED TO THE SECONDARY PORT ON THE CASSETTE TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE UNSPECIFIED CLAVE PORT, "CAME AWAY FROM THE SET AND WHEN WE TRIED TO SCREW IT BACK ON IT WOULD NOT TAKE HOLD." AN UNSPECIFIED VOLUME OF CHEMOTHERAPEUTIC SOLUTION LEAKED. NO MEDICAL INTERVENTIONS WERE REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC 5000 DUAL CHAMBER PUMPSET UNK FPA HOSPIRA COSTA RICA LTD. NA 771455H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED CLAVE PORT, MFR UNK