BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARLINK SYSTEM - TYPE CATH SET/MALE LUER LOCK ADAPTER

    MDR report key: 1023306 · Received April 1, 2008

    Report

    Report Number
    6000001-2008-00200
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL TUBING WAS DISCARDED. COMPANION SAMPLES ARE AVAILABLE AND HAVE BEEN RETURNED TO THE BAXTER FAILURE ANALYSIS LAB FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    INITIALLY, THE FACILITY WAREHOUSE MANAGER REPORTED A MICROBORE Y-TYPE CATHETER EXTENSION SET WITH 2 CLEARLINK LUER ACTIVATED VALVES AND MALE LUER LOCK ADAPTER SEPARATED AT THE MALE LUER LOCK CONNECTION FROM THE TUBE DURING A PT INFUSION OF MILRINONE (RATE AND AMOUNT UNK TO REPORTER) VIA A CADD PRISM PUMP. THERAPY WAS INTERRUPTED FOR AN UNSPECIFIED PERIOD OF TIME AND THE PT COMPLAINED OF CHEST PAINS. THE PT WAS SLEEPING WHEN THE INCIDENT OCCURRED AND THAT IT IS THOUGHT THAT THE PT ROLLED ON THE TUBING DURING HIS SLEEP. THE ISSUE WAS DETECTED BY A NURSE. NO INJURY WAS REPORTED. ADD'L INFO WAS RECEIVED FROM THE HOMECARE NURSE IN 2008: IN 2008, THE PT WAS READMITTED TO THE HOSPITAL DUE TO EDEMA OF THE LEGS AND INCREASED WEIGHT GAIN. AT THE TIME OF ADMISSION, THE PT WAS INFUSING DOBUTAMINE 5MCG/KG/MINUTE AND MILRINONE 0.75MCG/KG/MINUTE VIA A Y-SITE INTO ONE LUMEN OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) (DUAL LUMEN). NAFCILLIN 1GRAM Q 6 HOURS WAS INFUSING THROUGH THE SECOND LUMEN. THE PT WAS ON THE SURGICAL UNIT WHEN THE NURSE WAS CALLED BECAUSE THE PT WAS EXPERIENCING CHEST PAIN, SHORTNESS OF BREATH (SOB) AND HAD A DROP IN BLOOD PRESSURE (BP) (UNK LEVEL). IT IS UNK WHAT INTERVENTIONS WERE REQUIRED OR ADMINISTERED AT THIS TIME. THE HOSPITAL NURSE NOTED THAT SEPARATION OF THE CLEAR LINK EXTENSION SET HAD OCCURRED. REPORTEDLY, THE MALE LUER WAS STILL CONNECTED TO THE PICC LINE, BUT THE TUBING PORTION OF THE EXTENSION SET SEPARATED FROM THE MALE LUER. REPORTEDLY, THE EVENT OCCURRED IN 2008. THE PT HAD BEEN ADMITTED WITH PRODUCT (CLEAR LINK EXTENSION SET) AND PUMP (CADD) THAT HAD BEEN SUPPLIED BY FAIRLANE HEALTH SERVICES (HOME INFUSION SERVICES). THE HOMECARE NURSE WAS NOT ADVISED OF THE SEPARATION ISSUE UNTIL AFTER THE PT HAD LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM - TYPE CATH SET/MALE LUER LOCK ADAPTER 80FPA FPA BAXTER HEALTHCARE CORP. R06G12079

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention