BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS CONNECTOR

    MDR report key: 3168144 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00018
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATABASE RECORD REVIEW: A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST#/ SIMILAR ISSUE DID NOT IDENTIFY ANY ADDITIONAL REPORTS OR INVESTIGATIONS IDENTIFYING A MFG. DEFECT/ NONCONFORMANCE. CONCLUSION: THOROUGH TESTING OF THE RETURNED 20130-01 CONNECTOR AND MATING DEVICES RECORDED NO LEAKAGES AND OR PERFORMANCE ISSUES ALONG THE ENTIRE LENGTH OF THE FLUID PATH. THE 20130-01 SPIROS CONNECTOR MET PRODUCT SPECIFICATIONS AND PERFORMED AS INTENDED. THE EXACT CAUSE(S) OF THE REPORTED PRODUCT ISSUE REMAINS UNKNOWN.

    Description of Event or Problem · 1

    COMPLAINT REC'D CONCERNING A LEAKAGE INCIDENT WITH USE OF ONE (1) 20130-01, SPINNING SPIROS CONNECTOR, LOT # UNKNOWN. IT WAS REPORTED THAT DURING THE INFUSION "5-10 CC OF CHEMO (LIPOSOMAL DOXORUBICIN) LEAKED FROM SIDE OF SPIROS ON TO PATIENT. PHARMACIST DISCONTINUED INFUSION AND PUT ON NEW TUBING AND NEW SPIROS AND RESUMED INFUSION. NO HARM TO PATIENT." DEVICE/ RETURN: ONE (1) USED 20130-01, SPINNING SPIROS CONNECTED TO A INTERLINK BLUNT CANNULA TUBING SET, MATED/ ATTACHED TO BAG SPIKE WAS RECEIVED FOR ANALYSIS AND INVESTIGATION. VISUAL INSPECTION AND DIMENSIONAL ANALYSIS RECORDED NO OUT OF SPECIFIC CONDITIONS. FUNCTIONAL AND PERFORMANCE TESTING WAS CONDUCTED PER THE PRODUCT SPECIFICATIONS. THE RETURNED INTERLINK SET WITH THE 20130-01 SPIROS ATTACHED TO THE DISTAL END WAS PRESSURE LEAK TESTED IN BOTH THE ACTIVATED AND UN-ACTIVATED CONDITION. THE RESULTS RECORDED TO LEAKAGES FUNCTIONAL AND PERFORMANCE TESTING CONTINUED. THE RETURNED 20130-01 WAS REMOVED AND PRESSURE LEAK TESTED PER THE PRODUCT SPECIFICATION REQUIREMENTS. THE RESULTS RECORDED THE 20130-01 DEVICE PERFORMED AS EXPECTED WITH NO LEAKAGE IN EITHER THE ACTIVATED OR UN-ACTIVATED STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223402 SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 INTERLINK EXTENSION SET NOI| SYRINGE