BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK EXTENSION SET W/CONTROL-A-FLO REGULATOR

    MDR report key: 2060311 · Received April 15, 2011

    Report

    Report Number
    6000001-2011-02911
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K940867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR AN EVALUATION. THE UNIT WAS RECEIVED IN A BIOHAZARD BAG SINCE IT WAS CONTAMINATED WITH AN UNKNOWN SOLUTION. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WAS A SEPARATION IN THREE PIECES OF THE FLOW REGULATION DEVICE. THE REPORTED CONDITION WAS CONFIRMED; HOWEVER THE CAUSE OF THIS CONDITION HAS NOT BEEN IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE ON (B)(6) 2011 OF AN INTERLINK EXTENSION SET IN WHICH THE SET BURST DURING PATIENT USE WHILE INFUSING AN UNKNOWN MEDICATION ON AN UNKNOWN DATE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR THE FIRST BURST COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK EXTENSION SET W/CONTROL-A-FLO REGULATOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10G18021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION