BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 1963743 · Received December 22, 2010

    Report

    Report Number
    9615050-2010-00275
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED FOUR POSSIBLE LOT NUMBERS. THE POSSIBLE LOT NUMBERS ARE 920125H, 910235H, 910245H, AND 881995H. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO 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. THE PRIMARY PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF AN EXTENSION SET WAS CONNECTED TO THE CLAVE Y-SITE OF THE PRIMARY PLUMSET FOR DELIVERY OF AN UNSPECIFIED VOLUME OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED LEAKAGE OF THE CHEMOTHERAPEUTIC AGENT AT THE CONNECTION OF THE OPTION-LOK MALE ADAPTER AND THE CLAVE Y-SITE. THE VOLUME OF SOLUTION THAT LEAKED WAS NOT SPECIFIED. THE CUSTOMER CONTACT REPORTED THAT IT "APPEARS TO DRIP OUT VERY LITTLE FROM WHERE THE TUBING ATTACHES TO THE CLAVE (TO CHARACTERIZE AS IF THE SILICONE HAD A SMALL HOLE)." THE SPILL WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM LC OL CNVRTBL P 80FRN FRN HOSPIRA COSTA RICA LTD NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION SET, LIST #12654, LOT # UNK