BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU

    MDR report key: 19388143 · Received May 23, 2024

    Report

    Report Number
    9615050-2024-00411
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 04JUN2024. INVESTIGATION SUMMARYA PICTURE SHOWING THE INLINE FILTER WHERE BOTH THE INLET AND OUTLET FILTER APPEAR TO BE WET WAS RETURNED. RECEIVED TWO NEW LIST #142540489 PRIMARY PLUM SETS. NO DAMAGE OR ANOMALIES NOTED ON THE RECEIVED SETS. EACH SET WAS LEAK TESTED PER SPECIFICATION. AS RECEIVED ERRANT SOLVENT WAS OBSERVED ON THE SECONDARY PORT OF THE CASSETTE IN SAMPLE 1. THE PROBABLE CAUSE OF THE OBSERVED ERRANT SOLVENT IS DUE TO A SOLVENT APPLICATION ERROR IN COSTA RICA. NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. THE COMPLAINT OF LEAK COULD NOT BE REPLICATED ON THE NEW, UNUSED RETURNED SAMPLES HOWEVER IT CAN BE CONFIRMED BASED ON THE RETURNED IMAGE. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE LOT HISTORY FOR THE PROVIDED POSSIBLE LOT NUMBERS WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    E SECTION ADDITIONAL CONTACT INFORMATION: DISTRIBUTOR (B)(4), QRA, SR. SPECIALIST, POST MARKET VIGILANCE. (B)(4) COMPLAINT REFERENCE #: (B)(4). ((B)(6), SR. SPECIALIST, POST MARKET VIGILANCE, FORWARDED COMPLAINT FROM (B)(6), RA/QA MANAGER OF (B)(6) ON BEHALF OF CUSTOMER). THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOT) OF ITEM NUMBER. 142540489: LOT#: 13803947, D4: EXPIRY DATE: 01 NOV 2026, H4: MFR DATE: 01 NOV 2023. LOT#:13684576, D4: EXPIRY DATE: 01 JUL 2026, H4: MFR DATE: 01 JUL 2023. H3 - REASON DEVICE NOT EVALUATED BY MFG - THE CUSTOMER INDICATED DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    ICU MEDICAL RECEIVED A REPORT OF LEAKAGE REGARDING A PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECURE LOCK, 112 INCH . IT WAS REPORTED THAT THE NURSE WENT TO CLAMP THE PACLITAXEL LINE CLOSED AS CARBO INFUSION BEGAN NOTICED FILTER ON PACLITAXEL TUBING WAS ALL WET. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244790 PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PACLITAXEL.