BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS MICROBR EXT SET

    MDR report key: 1816329 · Received August 16, 2010

    Report

    Report Number
    9613251-2010-00108
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE EXPECTED TO BE RETURNED FOR INVESTIGATION. THEY HAVE NOT YET BEEN RECEIVED. THE CATALOG NUMBER 11402 HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DELAYS IN CRITICAL FOLLOWING DIFFICULT DISCONNECTIONS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. THE T-CONNECTORS ON THE DISTAL END OF THE TUBING SETS WERE CONNECTED DIRECTLY TO THE PATIENT'S CATHETERS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE CLINICIANS ATTEMPTED TO DISCONNECT THE T-CONNECTORS FROM THE CATHETERS TO DELIVER UNSPECIFIED MEDICATIONS. THE CUSTOMER CONTACT REPORTED, "THIS HAS HAPPENED IN UNSPECIFIED CODE SITUATIONS WHEN THEY NEED TO DELIVER MEDICATIONS QUICKLY AND CLOSER TO THE PATIENT, WITHOUT ADDING ADDITIONAL FLUSHING FLUID TO THE PATIENT." THE CUSTOMER CONTACT REPORTED THAT, "THEY USE HEMOSTATS TO GET THE CONNECTIONS APART AND IF THEY STILL CANNOT GET THE CONNECTIONS APART IN CRITICAL SITUATIONS, THEY WILL ADMINISTER THE INFUSIONS INTO A PORT FURTHER DOWN THE LINE OF THE EXTENSION SETS LEAVING THE LINES INTACT." THE CUSTOMER CONTACT STATED, "THIS RESULTS IN THE PATIENTS RECEIVING ADDITIONAL FLUID FROM THE LINES." IT WAS ALSO REPORTED THAT ON AN UNSPECIFIED NUMBER OF INSTANCES WHEN HEMOSTATS WERE USED TO DISCONNECT THE TUBING SETS, THE MALE ADAPTERS OF THE T-CONNECTORS CRACKED OR BROKE IN THE CONNECTION SITES. THE TUBING SETS WERE THEN REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS MICROBR EXT SET UNK FPA HOSPIRA LTD. NA 78096NS

    Patients

    Seq Age Sex Outcome Treatment
    1