BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2311363 · Received October 21, 2011

    Report

    Report Number
    9610825-2011-00142
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 22, 2011
    Report Date
    October 21, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4) INTERNAL REPORT # (B)(4). B BRAUN MEDICAL INC FORMED A CROSS-FUNCTIONAL WORKING GROUP WITH MEMBERS FROM QUALITY, ENGINEERING, SVC, SALES, CLINICAL AND TECHNICAL SUPPORT AND PRODUCT MGMT WITH THE PURPOSE TO INVESTIGATE AND BRING RESOLUTION TO THE EVENTS REPORTED TO B BRAUN FROM (B)(6) HOSP. B BRAUN TOOK A THREE-PRONGED APPROACH TO THIS INVESTIGATION: CLINICAL ON-SITE ASSESSMENT. BIOMEDICAL ON-SITE ASSESSMENT - INCLUDED PREVENTATIVE MAINTENANCE AND REPAIRS AS NEEDED ON ALL PUMPS. CUSTOMER COMPLAINT INVESTIGATION. THE CLINICAL ON-SITE ASSESSMENT WAS CONDUCTED FROM (B)(4) 2011 BY B BRAUN CLINICAL PERSONNEL. DURING THIS ASSESSMENT, ALL HOSP SHIFTS WERE COVERED AND A TOTAL OF 188 CLINICIANS WERE INCLUDED FROM 14 DIFFERENT AREAS OF CARE. THIS ASSESSMENT REVEALED NO USER RELATED ISSUES THAT COULD HAVE LED TO THIS EVENT. CUSTOMER COMPLAINT INVESTIGATION RESULTS: A JOINT REVIEW OF THE DEVICE HISTORY LOG WAS CONDUCTED WITH B BRAUN AND REPORTING FACILITY AND IT APPEARED THAT THE DEVICE LOG MATCHED THE CLINICAL ACCOUNT. THERE WAS A SYS ERROR 2153 DURING THE INITIAL SET-UP OF THE DRUG LIBRARY. THIS ERROR CODE IS FOR A SELF-CORRECTING INTERNAL ERROR, WHICH DOES NOT APPEAR TO BE ASSOCIATED WITH THE EVENT. THERE WERE NO FURTHER INFUSIONS PERFORMED AFTER THE SYS ERROR. IT WAS NOTED DURING THE REVIEW THAT THE DRUG LOSS ON THE FLOOR COULD HAVE OCCURRED DURING PRIMING OR LOADING THE IV SET INTO THE PUMP. THE ACTUAL PUMP IN THE REPORTED INCIDENT WAS RETURNED FOR EVAL AND VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT A RATE OF 24.5 ML/HR AND A VOLUME OF 50 ML. THE TEST RESULTS WERE WITHIN SPECS AT 50.6 ML, 50.5 ML AND 50.5 ML. THERE WERE NO ALARMS OBSERVED DURING THE VOLUMETRIC TESTING. IN ADDITION, THERE WAS NO FREE FLOW CONDITION THAT COULD BE REPLICATED WITH THE DOOR OPENED OR CLOSED. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP APPEARED TO OPERATE AS PROGRAMMED AND FUNCTIONED AS INTENDED. AT THIS POINT NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CAUSE OF THE EVENT, BUT IT IS POSSIBLE THAT THE EVENT COULD BE ATTRIBUTED TO ALLOWING THE FLUID TO RUN ON THE FLOOR DURING PRIMING OR LOADING PRIOR TO THE SET BEING PLACED INTO THE INFUSION PUMP. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR. IF ADD'L PERTINENT INFO BECOMES AVAILABLE FROM THE MFR, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS OVER-INFUSION. ANGIOMAX 50ML BAG RUN AS A PRIMARY INFUSION. NURSE LOADED SET AND CONFIRMED "ORIGINAL SPACE LINE." NURSE PROGRAMMED "WEIGHT" AND PUMP HAD LOUD ALARM (INTERNAL ALARM 2153). NURSE THEN NOTICED BAG WAS EMPTY AND PUDDLE OF FLUID ON FLOOR. NURSE CLAIMS FLUID MUST HAVE FREE FLOWED THROUGH PUMP. IV WAS NOT CONNECTED TO PT. NO PT INJURY REPORTED. ADD'L INFO RECEIVED FROM MEDWATCH INDICATES THE RN WAS LOADING THE IV PUMP TO INFUSE ANGIOMAX. THE RN PRIMED THE TUBING AND LOADED IT INTO THE PUMP. SHE USED THE DRUG LIBRARY AND IT ASKED HER TO ENTER THE WEIGHT OF THE PT. WHILE SHE ENTERED THE PT WEIGHT OF (B)(6), THE PUMP MADE A LOUD NOISE (ALARMED) AND SHE HIT THE STOP BUTTON AND NOTICED ALL OF THE MEDICATION HAD COMPLETELY DRAINED OUT OF THE BAG AND ONTO THE FLOOR. THE PT WAS NOT CONNECTED TO THE LINE AT THE TIME. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other