BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 1961618 · Received December 27, 2010

    Report

    Report Number
    9615050-2010-00277
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 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 UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED FOUR POSSIBLE LOT NUMBERS. THE POSSIBLE LOT NUMBERS ARE 920125H, 910235H, 910245H, AND 881995H. 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 CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, LEAKAGE OF THE CHEMOTHERAPEUTIC AGENT WAS NOTED FROM AN UNSPECIFIED LOCATION. THE VOLUME OF SOLUTION THAT LEAKED WAS NOT SPECIFIED. THE SPILL WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. IT WAS REPORTED THAT THE PATIENT'S THERAPY WAS CANCELLED FOR THE DAY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. 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: (B)(4), LOT #UNK