BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY SET, 15 MICRON FILTER IN SIGHT CHAMBER, SECURE LOCK, 86 CM

    MDR report key: 9311846 · Received November 12, 2019

    Report

    Report Number
    9615050-2019-00453
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 28, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887709100227
    PMA / PMN Number
    K142367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED 140289291 SECONDARY SET ATTACHED TO ONE USED 140019291 PRIMARY PLUM SET ON 11/22/2019. THE REPORTED PRODUCT ISSUES COULD NOT BE CONFIRMED ON THE RECEIVED SECONDARY SET. THE PRODUCT WAS ATTACHED TO AN ICU MEDICAL PROVIDED IV BAG, PRIMED PER PACKAGING DIRECTIONS AND A FLOW TEST WAS PERFORMED USING AN ICU PLUM PUMP. THERE WERE NO DIFFICULTIES IN PRIMING, NO CASSETTE ERRORS, NO OCCLUSION ALARMS WERE GENERATED, NO AIR IN LINE ALARMS WERE GENERATED, NO LEAKAGES OCCURRED AND OR RESTRICTIONS IN FLOW WERE OBSERVED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 4103165 WAS REVIEWED AND NO NONCONFORMANCE WAS FOUND THAT COULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SECONDARY SET THAT AFTER THE OXALIPLATIN INFUSION WAS COMPLETED, AND THE ADMINISTRATION SET WAS BEING USED TO FLUSH THE REMAINING MEDICATION THROUGH THE LINE WITH 50ML GLUCOSE 5% FLUSH, THE PLUM 360 PUMP ALARMED FOR AIR IN LINE. AIR WAS NOTED IN THE ADMINISTRATION SET TUBING AND IT WAS REPORTED THAT THE REMAINING 20MLS OF OXALIPLATIN TREATMENT WERE DISPOSED OF DUE TO RISK OF AIR BEING INFUSED ALONG WITH THE DRUG. THERE WAS NO NEW LINE SET UP THE LINE WAS HAND FLUSHED. THERE WAS NO ADVERSE EVENT, ALTHOUGH THERE WAS UNPROTECTED CHEMO EXPOSURE REPORTED AS A DROP OF OXALIPLATIN WAS NOTED AT THE END OF THE ADMINISTRATION SET WHEN DISCONNECTING THE SET FROM THE CANNULA, AND ALSO FOR THE PERSON COLLECTING THE ADMINISTRATION SET. THE CUSTOMER REPORTED ADVERSE OPERATOR CONSEQUENCE AS THERE WAS A POTENTIAL OF CHEMOTHERAPY EXPOSURE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107508 SECONDARY SET, 15 MICRON FILTER IN SIGHT CHAMBER, SECURE LOCK, 86 CM SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 4103165 10887709100227

    Patients

    Seq Age Sex Outcome Treatment
    1 OXALIPLATIN, MFR UNK| PLUM 360 INFUSION PUMP SN: (B)(4).| PRIMARY PLUMSET, LN 140019291, LOT #4174067