BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASITE HORIZON PUMP IV SET

    MDR report key: 1122504 · Received August 15, 2008

    Report

    Report Number
    9614279-2008-00031
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 11, 2008
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K952631
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THIS INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS SET LEAKING AT Y SITE. FOUND WHILE CHEMO INFUSING. NO PATIENT INJURY, DID HAVE SMALL CHEMO SPILL WITH SET. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED NO ONE SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE HORIZON PUMP IV SET UNIVERSAL IV SET FPA B. BRAUN MEDICAL INC. N/A 60995143

    Patients

    Seq Age Sex Outcome Treatment
    1 Other