BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5378004 · Received January 19, 2016

    Report

    Report Number
    9610825-2016-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Report Date
    January 8, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). RESULT OF EXAMINATION: THE INFUSOMAT SPACE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. EXTERNALLY SIGNS OF A DROP DOWN WERE ASSESSED. A GAP BETWEEN OPERATING UNIT AND HOUSING WAS DETECTED. THE DEVICE SHOWED AGE-BASED MARKS OF USE AND WAS SLIGHTLY CONTAMINATED. THE SPACELINE, WHICH WAS ENGAGED FOR TECHNICAL PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. FOR CHECKING THE DELIVERY ACCURACY THE DEVICE WAS TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK THREE TIMES AND A MEASUREMENT ACCORDING TO EN 60601-2-24 WAS PERFORMED. ALL MEASURED VALUES WERE WITHIN SPECIFICATION. INSIDE WE FOUND DAMAGES OF A DROP DOWN. HOWEVER, THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. FOLLOWING IS DESCRIBED IN THE IFU: · PRIOR TO ADMINISTRATION, VISIBLY INSPECT THE PUMP FOR DAMAGE, MISSING PARTS OR CONTAMINATION AND CHECK AUDIBLE AND VISIBLE ALARMS DURING SELF TEST. · IF THE PUMP FALLS DOWN OR IS EXPOSED TO FORCE, IT MUST BE CHECKED BY THE SERVICE DEPARTMENT. CORRECTION: CHANGE FROM : SECTION D1 - BRAND NAME : PERFUSOR SPACE, SECTION D2 - COMMON DEVICE NAME : SYRINGE PUMP, SECTION D4 - CATALOG # : 8713030, SECTION G5 - PMA/510K #: K062699. CHANGE TO: SECTION D1 - BRAND NAME : INFUSOMAT SPACE, SECTION D2 - COMMON DEVICE NAME : INFUSION PUMP, SECTION D4 - CATALOG # : 8713050, SECTION G5 - PMA/510K #: K062700.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM USER FACILITY TO BBM LABORATORY IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): THE PUMP WAS SET FOR 8 ML/HR,. VTBU WAS 90 LESS THAN TWO HOURS LATER THE PUMP HAD INFUSED THE 90ML. CUSTOMER INFORMATION: THE PATIENT WAS ACCESSED AND APPARENTLY THERE WAS NO EXTREME HARM (FROM WHAT WE HAVE BEEN TOLD, THE PATIENT RECEIVED 90 ML PROPOFOL IN JUST UNDER 2 HOURS. THE CUSTOMER HAS FOUND THE PUMP TO BE DAMAGED, NOTICED AFTER REMOVING THE SET THE DOOR DOESN'T LINE UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34846 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1