BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS®

    MDR report key: 9634266 · Received January 27, 2020

    Report

    Report Number
    9617594-2020-00022
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709077201
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE USED CL3931, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS W/RED CAP, CLAMP (LOT# 4172961) WAS RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, A SLIGHT SLIT PROPAGATION WAS SEEN ON THE TOP SURFACE OF THE MICROCLAVE SEAL. NO OTHER DAMAGE OR ANOMALIES WERE IDENTIFIED. NO MATING DEVICES WERE RETURNED. THE CL3931 SET WAS HYDROSTATIC PRESSURE LEAK TESTED ACCORDING TO PRODUCT PERFORMANCE SPECIFICATIONS. LEAKAGE OCCURRED FROM THE DISTAL END OF THE CHEMOLOCK PORT WHILE IT WAS IN THE UNACTIVATED STATE. DURING TESTING, THE CHEMOLOCK PORT WAS MANUALLY PULLED FROM THE BOND POCKET OF THE Y-CONNECTOR WITH LITTLE EFFORT. SOME SOLVENT WAS IDENTIFIED ON THE POST OF THE CHEMOLOCK PORT AND WITHIN THE BOND POCKET. THE REPORTED COMPLAINT OF LEAKAGE WAS CONFIRMED. THE LEAK OCCURRED AT THE INTERFACE BETWEEN THE POST OF THE CHEMOLOCK PORT AND THE BOND POCKET OF THE Y-CONNECTOR. THE PROBABLE CAUSE OF THE LEAK IS DUE TO AN ERROR IN THE MANUAL BONDING PROCESS DURING MANUFACTURING. A DEVICE HISTORY REVIEW (DHR) FOR LOT# 4172961 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. TESTING IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP, CLAMP, THAT WHEN ADMINISTERING MELPHALAN TO A HOSPITAL INPATIENT, VIA AN UNSPECIFIED PUMP, LEAKING WAS DISCOVERED COMING FROM THE BACKSIDE OF THE CHEMOLOCK PORT WHERE IT IS BONDED ON THE Y-SITE OF THE EXTENSION SET. THE TUBING SET UP WAS THE LINE WAS PRIMED WITH SALINE FROM THE RESCUE LINE, AND THEN ATTACHED TO THE PATIENT. THE CLINICIAN DID NOT PRIME AT THE CHEMOLOCK PORT. THE EXTENSION SET HAD BEEN IN USE FOR 1 HOUR AND THE LEAK WAS NOTED WHEN THE CLINICIAN CHECKED ON THE PATIENT AT 8AM. THERE WAS ONLY A SMALL AMOUNT OF LEAKAGE BEFORE IT WAS CAUGHT. IT WAS REPORTED THAT THE CHEMOTHERAPY MEDICATION CAME IN CONTACT WITH THE PATIENT AND THE CLINICIAN. THE PATIENT WAS WASHED WITH SOAP AND WATER AND THE SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE EXTENSION SET WAS REPLACED BUT THE DRUG WAS NOT REPLACED SINCE THERE WAS 100-125ML LEFT OF A 1000ML INFUSION WHEN THE LEAK OCCURRED. AS THE LEAK WAS NOT FROM THE BAG SIDE (THAT CHEMOLOCK ATTACHMENT WAS PATENT) THE CHEMOLOCK EXTENSION SET WAS REPLACED AND THE REMAINDER OF THE DRUG WAS INFUSED WITHOUT INCIDENT. THERE WERE NO DEFECTS NOTED. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO HARM WAS DONE AS A RESULT OF THE REPORTED EVENT, NO BLOOD LOSS OR BLEED BACK, AND NO DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97282 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CL3931 4172961 00887709077201

    Patients

    Seq Age Sex Outcome Treatment
    1 MELPHALAN, UNK MFR| UNSPECIFIED PUMP, UNK MFR