BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIROS CONNECTOR

    MDR report key: 3313578 · Received August 16, 2013

    Report

    Report Number
    2025816-2013-00077
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: CODE - F/U WITH FACILITY FOR THEIR INTERNAL ASSESSMENT, THE FOLLOWING INFO WAS REPORTED: IT APPEARS THAT THE LEAK OR DISCONNECT WAS FROM AN ASSUMED BAD CONNECTION OF THE SPIROS TO THE SMARTSITE. THE SPIROS NEVER COMPLETELY SEPARATED FROM THE SMARTSITE (HENCE FLUID STILL FLOWED) BUT IT APPEARS THE NURSE THAT ATTACHED IT WAS NEWER AND MOST LIKELY DID NOT TIGHTLY SECURE THE SPIROS TO THE SMARTSITE. THERE WAS NO DISCONNECTION OF THE DISTAL END OF THE TUBING FROM THE BACK END OF THE SPIROS WHICH WAS INITIALLY SUSPECTED." A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR PROBLEM DID RECORD ADD'L REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATIONS WHERE DEVICES WERE RETURNED/ANALYZED RECORDED MIXED RESULTS, INCLUDING USAGE, NO DEFECT FOUND, MFG/DESIGN AND CANNOT DETERMINE. CONCLUSION: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS OR INVESTIGATION. CAUSE OF THE INCIDENT REMAINS UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING DISCONNECT/LEAKAGE ISSUES INVOLVING SET-UP/USE OF 20130-01 SPINNING SPIROS AND CAREFUSION PUMP SMARTSITE TUBING SET. IT WAS INITIALLY REPORTED THAT A PT WAS FOUND DURING CHEMO INFUSION TO HAVE HAD A SPIROS DISCONNECTED FROM THE DISTAL END OF THE CAREFUSION PUMP SET. THERE WAS A "POOL OF BLOOD" ON THE FLOOR WHEN FOUND. CBC WAS ORDERED. NURSE MANAGER REPORTED THIS WAS ALSO REPORTED BY STAFF THAT ANOTHER OCCURRENCE OF DISCONNECT HAD HAPPENED BUT NO DETAILS, DATE, GIVEN OTHER THAN IT WAS NOT SIGNIFICANT." NO REPORTED ADVERSE PT OR OPERATOR CONSEQUENCES. F/U WITH FACILITY STAFF MANAGEMENT CONFIRMED THE INVOLVED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398471 SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CAREFUSION SMARTSITE PUMP SET| SYRINGE