BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE PUMP SETS WITH ULTRASITE

    MDR report key: 4254753 · Received November 6, 2014

    Report

    Report Number
    9614279-2014-00043
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MED INC INTERNAL REPORT # (B)(4). THREE USED SPACE PUMP IV SETS, WITHOUT PACKAGING, WERE RECEIVED FOR EVALUATION. THE STS WERE SUBJECTED TO AN AIR PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THERE WERE NO LEAKAGES OBSERVED AT ANY OF THE TUBING CONNECTIONS. BOTH ULTRASITE Y-SITES ON ALL THREE SETS WERE THEN ACCESSED WITH A SYRINGE, AND THE SETS WERE RE-TESTED. DURING THIS TEST, NO LEAKAGES WERE OBSERVED FROM ANY LOCATION ON THE SETS. NO ADVERSE QUAL TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR INVOLVED ULTRASITE VALVE MATERIAL NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. THE RETURNED SAMPLES MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. IF ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS LEAKAGE AT THE LOWER Y-SITE WHERE THE Y-SITE CONNECTS TO THE TUBING. THE MEDICATION USED WAS A CHEMO DRUG, ETOPOSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714262 INFUSOMAT SPACE PUMP SETS WITH ULTRASITE SPACE PUMP IV ADMIN SET FPA B. BRAUN OF DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK