BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2771645 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01515
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED TWO UNUSED PHASEAL LUER LOCK INJECTORS((B)(4), LOT 2163410) AND TWO UNUSED PHASEAL LUER LOCK CONNECTORS ((B)(4), LOT 2070910). FOR THE PURPOSE OF TESTING, AN UNUSED IN-HOUSE CLEARLINK(PRODUCT CODE2C8537, LOT R10B02125) WAS USED. THE PHASEAL LUER LOCKS AND CONNECTORS WERE ASSEMBLED. THE IN-HOUSE CLEARLINK PRIMARY SET WAS THEN SPIKED INTO AN IN-HOUSE 1000ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER. ONE PHASEAL ASSEMBLY WAS THEN ATTACHED TO BOTTOM/THIRD CLEARLINK Y-SITE. THE OTHER ASSEMBLY WAS ATTACHED TO THE TOP/ FIRST CLEARLINK Y-SITE. AN IN-HOUSE (B)(4) SECONDARY SET SPIKED INTO AN IN-HOUSE 100ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER WAS THEN ATTACHED TO EACH PHASEAL ASSEMBLY. BOTH SAMPLES WERE THEN CHECKED FOR FLOW. BOTH SAMPLES FLOWED NORMALLY WITH NO INTERRUPTION NOTED. THE PHASEAL ASSEMBLIES WERE THEN REMOVED AND THE CLEARINK GLANDS CHECKED FOR DAMAGE, WITH NONE NOTED. THE PHASEAL LUER CONNECTORS WERE VISUALLY INSPECTED FOR EXCESSIVE FLASH, WITH NONE NOTED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A NO FLOW WAS OBSERVED. ACCORDING TO THE REPORT, THE CLEARLINK ON THE LOWEST Y-SITE WOULD NOT ALLOW FOR FLOW TO BE ESTABLISHED WHEN PUSHING MEDICATION THROUGH IT. THE FACILITY INDICATED THAT CLEANSING WITH AN ALCOHOL SWAB WILL ALLOW FOR FLOW TO BE ESTABLISHED. THE REPORTED INDICATED THAT THE Y-SITE WAS IN USE WITH A PHASEAL DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 PHASEAL