BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS, SPINNING CONNECTOR

    MDR report key: 4742992 · Received April 28, 2015

    Report

    Report Number
    2025816-2015-00025
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 28, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE TWO POTENTIAL 20130-01 LOT# 39-959-SJ (MFG DATE 03/2014) SHOWED (B)(4) UNITS AND LOT# 38-498-SJ (MFG 03/2014) ALSO SHOWED (B)(4) UNITS WERE ALL MFG, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILDS. DEVICE RETURN: A TOTAL OF (B)(4) PACKAGED 20130-01 DEVICES FROM THE TWO POTENTIAL LOT# WERE RETURNED FOR ANALYSIS AND INVESTIGATION. THE RETURNED SAMPLES WERE PRESSURE LEAK TESTED PER THE APPLICABLE PERFORMANCE SPEC. THE RESULTS RECORDED THE 20130-01 SPINNING SPIROS CONNECTORS MET ACTIVATED AND UNACTIVATED PRESSURE LEAK TESTING PER THE PROD PERFORMANCE SPEC. THERE WERE NO ATTACHMENT, LEAKAGE ISSUES REPLICATED WITH ANY OF THE SAMPLES TESTED. FINDINGS: THE INVOLVED 20130-01 SPINNING SPIROS CONNECTOR WAS DISCARDED. PACKAGED/UNUSED SAMPLES FROM TWO POTENTIAL LOTS WERE TESTED. THE RETURNED SAMPLES MET THE PERFORMANCE SPEC.

    Description of Event or Problem · 1

    (B)(4) REPORT REC'D RECEIVED CONCERNING LEAKAGE ISSUES WERE 20130-01 SPINNING SPIROS CONNECTORS WERE IN USE. THE (B)(4) REPORT DESCRIBES THE EVENTS AS FOLLOWS: "NURSES HAVE ENCOUNTERED THEIR PTS CYCLOSPORINE DOES HAS BEEN LEAKING... NOTED CRACKS IN THE SPINNING SPIROS CONNECTION PIECE THAT IS ATTACHED TO THE SYRINGE. THE PHARMACY HAS BEEN DRAWING UP THESE CHEMOTHERAPY DOSES". ALTHOUGH REQUESTED ADD'L. DEVICE SET-UP; STORAGE CONDITIONS; USAGE AND DRUG FORMULATION/STRENGTH INFO WAS REQUESTED, THERE HAS BEEN NO RESPONSES FROM THE FACILITY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277306 SPIROS, SPINNING CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI 30CC SYRINGE| PUMP DELIVERY TUBING SETS