BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3400 SYRINGE PUMP

    MDR report key: 728364 · Received June 15, 2006

    Report

    Report Number
    9612511-2006-00022
    Event Type
    Malfunction
    Date Received
    June 15, 2006
    Report Date
    June 13, 2006
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD. (PREVIOUSLY GRASEBY MEDICAL LTD.)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF A FINDING DURING A RECENT INSPECTION, (FDA FORM FDA, FEI 3002088009) THE CO COMMITED TO REVIEW ALL COMPLAINTS FROM THE LAST 24 MONTHS TO IDENTIFY ANY THAT MIGHT BE CONSIDERED REPORTABLE WHICH HAVE NOT BEEN REPORTED. THAT REVIEW HAS BEEN COMPLETED AND THE FOLLOWING MEDWATCH FORMS REPRESENT ALL SUCH LATE REPORTS. RESULT AND CONCLUSION OF MFR'S INVESTIGATION: REPORTED FAULT CANNOT BE REPLICATED AND THE PUMP IS FUNCTIONING CORRECTLY.

    Description of Event or Problem · 1

    OUR REF: 2005 0708/3/1 - MHRA REF: 2005/006/023/401/005 - NO REPORTED PT INJURY OR MEDICAL INTERVENTION. PUMP SET TO INFUSE AT 5MLS/HR. WHEN STAFF RETURNED PUMP ALLEGED TO BE RUNNING AT 99MLSHR. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3400 SYRINGE PUMP SYRINGE PUMP FRN SMITHS MEDICAL INTERNATIONAL LTD. (PREVIOUSLY GRASEBY MEDICAL LTD.) 3400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *