BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PRIM PLUMSET-SL PE-LINED

    MDR report key: 11665523 · Received April 14, 2021

    Report

    Report Number
    9615050-2021-00044
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 23, 2021
    Report Date
    March 23, 2021
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005315
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #123390488, PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH; LOT #4840554 ONE USED. LIST #UNKNOWN, BAG SPIKE ADAPTER WITH SPIROS; LOT #UNKNOWN. THE COMPLAINT OF LEAKAGE COULD BE CONFIRMED. THE PRODUCT WAS TESTED PER PRODUCT SPECIFICATION. THERE WAS A LEAK FROM THE FILTER MATERIAL ON THE VENT PLUG JUNCTURE WITH THE CAP OPEN. THE LEAKS APPEARED TO SEEP THROUGH FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. THE PROBABLE CAUSE OF LEAKAGE IS DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE INTERACTION DURING USE. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED 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 PLUM SET WHERE THE CUSTOMER REPORTED AN UNSPECIFIED CHEMOTHERAPY LEAK ON THE FILTER VENT CONNECTED TO THE IV BAG DURING INFUSION. ADDITIONALLY, THE CUSTOMER STATED THE TUBING WAS WASHED WITH NORMAL SALINE. THERE WAS PATIENT INVOLVEMENT AND NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563428 LS PRIM PLUMSET-SL PE-LINED SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1233912 4840554 10887787005315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CHEMOTHERAPY, MFR UNK.| UNSPECIFIED CHEMOTHERAPY, MFR UNK.