BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    MDR report key: 1944212 · Received December 6, 2010

    Report

    Report Number
    9615050-2010-00249
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 10, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K052722. 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 LEAK OF A CHEMOTHERAPEUTIC AGENT. A PRIMARY TUBING SET WAS CONNECTED TO THE PATIENT'S PERIPHERAL IV ACCESS SITE AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF HERCEPTIN AT A RATE OF 547 ML/HR VIA AN UNSPECIFIED PUMP. IT WAS REPORTED THAT PRIOR TO THE COMPLETION OF THE HERCEPTIN DELIVERY, THE NURSE CONNECTED THE MALE ADAPTER OF ANOTHER PRIMARY TUBING SET TO THE UPPER CLAVE PORT OF THE TUBING SET THAT WAS DELIVERING THE HERCEPTIN. THE SECOND PRIMARY TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE AND AN UNSPECIFIED VOLUME OF TAXOL AT AN UNSPECIFIED RATE VIA A SECOND UNSPECIFIED PUMP. THE NURSE REPORTED THAT WITH EACH PULSATION FROM THE PUMP FOR THE HERCEPTIN DELIVERY, DROPS OF FLUID LEAKED FROM THE UPPER CLAVE PORT CONNECTION. THE DELIVERY OF HERCEPTIN WAS STOPPED. THE LEAK WAS CLEANED UP ACCORDING TO THE HOSPITAL'S PROTOCOL. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF 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 LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIFESHIELD PRIMARY TUBING SET, LIST # 19718,| LOT #UNK