BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2080663 · Received May 6, 2011

    Report

    Report Number
    6000001-2011-03773
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PRIMARY SET WAS USED BUT THE PRODUCT INFORMATION IS UNKNOWN. IT IS UNKNOWN IF THE SET WAS BACKPRIMED OR PRIMED PRIOR TO CONNECTING, HOWEVER, ONCE THE SECONDARY WAS CONNECTED TO THE PRIMARY THERE WAS NO FLOW. THE CONDITION OCCURRED DURING PATIENT USE WITH AN UNKNOWN ANTIBIOTIC. THE SOLUTION BAG WAS SQUEEZED TO INITIATE FLOW AND THE CHECK VALVE WAS INVERTED AND TAPPED. A SIGMA PUMP WAS USED AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NEITHER A SAMPLE NOR LOT NUMBER WERE PROVIDED BY THE CUSTOMER. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MEDICATION HUNG VIA CLEARLINK SECONDARY MEDICATION TUBING WAS ADMINISTERED VIA GRAVITY FLOW AND THE MEDICATION WAS NOT DRIPPING (PRIMARY BAG INFUSED). THE TUBING WAS CHANGED AND SECONDARY MEDICATION INFUSED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY SET, MEDICATION BAG