BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM SOL 2INTG CLAVE

    MDR report key: 1812386 · Received August 17, 2010

    Report

    Report Number
    9615050-2010-00154
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICES WERE DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DELAYS IN CRITICAL THERAPIES FOLLOWING DIFFICULT DISCONNECTIONS. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED SOLUTIONS. THE OPTION-LOK MALE ADAPTERS ON THE DISTAL END OF THE TUBING SETS WERE CONNECTED DIRECTLY TO THE PTS' CATHETERS. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE CLINICIANS ATTEMPTED TO DISCONNECT THE OPTION-LOK MALE ADAPTERS 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 PT, WITHOUT ADDING ADDITIONAL FLUSHING FLUID TO THE PT". 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 PTS 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 CRACKED OR BROKE IN THE CONNECTION SITES. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT 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 PLM SOL 2INTG CLAVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA 851555H

    Patients

    Seq Age Sex Outcome Treatment
    1