BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 4810513 · Received May 28, 2015

    Report

    Report Number
    9610825-2015-00205
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    March 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HISTORY FILES WERE READ AND ANALYZED. THE INDICATED BEHAVIOR WAS NOT COMPREHENSIBLE. THEREUPON THE DEVICE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. SOME SLIGHTLY EXTERNAL DAMAGES WERE DETECTED. THE DEVICE SHOWED AGE-BASED MARKS OF USE. THE DEVICE PASSED THE SELF TEST WITH A POSITIVE RESULT. THE SYRINGE, WHICH WAS ENGAGED FOR TESTING PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. THE LONG TERM TEST COULD NOT REPRODUCE THE REPORTED FAILURE. FOLLOWING, A DELIVERY ACCURACY MEASUREMENT ACCORDING (B)(4) WAS ARRANGED. THE INSIDE OF THE PUMP REVEALED SOME DAMAGES, BUT THESE ARE NOT RELATED TO THE INDICATED REASON OF COMPLAINT. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. NO SPECIFIC CONCLUSION CAN BE MADE. FOLLOWING IS DESCRIBED IN THE IFU: PRIOR TO ADMINISTRATION, VISIBLY INSPECT THE PUMP AND THE ACCESSORIES (ESPECIALLY THE AXIAL FIXATION) FOR DAMAGE, MISSING PARTS OR CONTAMINATION AND CHECK AUDIBLE AND VISIBLE ALARMS DURING SELFTEST.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM THE USER FACILITY TO (B)(4) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(4)): (B)(6) HOSP HAVE REPORTED A PERFUSOR SPACE PUMP THAT HAS REPORTEDLY OVER-INFUSED. INFUSION WAS HEPARIN, PT WAS MONITORED BY MEDICAL STAFF AND BLOOD TAKEN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346727 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1