BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2888293 · Received December 21, 2012

    Report

    Report Number
    9610825-2012-00276
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 28, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN INTERNAL REPORT# (B)(4). IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER STATED THE PUMP INVOLVED IN THE REPORTED INCIDENT WAS RUNNING WITH THE SAME INFUSION RATE (5ML/ 100ML BAG)FOR APPROXIMATELY FOR 21 DAYS (11/1/2012-11/22/2012). THE I.V SET WAS BEING CHANGED EVERY 72 HOURS. THERE WERE NO OTHER ISSUES PRIOR TO THE REPORTED EVENT DATE (11/22/2012). ON THE DAY OF THE REPORTED EVENT, ONE BAG WAS HUNG PRIOR TO THE REPORTED INCIDENT, AND THE BAG HAD INFUSED IN ABOUT 13 HOURS. A SECOND BAG WAS THEN HUNG, AND THE BAG HAD INFUSED IN ABOUT TWO AND A HALF HOURS. THE REPORTER CONFIRMED THERE WAS NO PATIENT INJURY OR INTERVENTION NEEDED. THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009 B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN INTERNAL REPORT # (B)(4). THE ACTUAL PUMP INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES WITH A VOLUME TO BE DELIVERED OF 5ML AT 12.45ML/H RATE. THE RESULTS WERE ALL WITHIN SPECIFICATION: 1ST TEST: 12.51ML IN 2 HOURS AND 00 MINUTES. 2ND TEST: 12.53ML IN 2 HOURS AND 00 MINUTES. 3RD TEST: 12.50ML IN 2 HOURS AND 00 MINUTES. THE PUMP'S OPERATIONAL LOG WAS REVIEWED FOR THE DAY OF THE REPORTED INCIDENT, 11/22/2012.ON 11/21/2012 AT 10:27:30AM A VTBI OF 50ML WAS ENTERED WITH THE PREVIOUSLY ENTERED IN RATE OF 5ML/HR. THE PUMP WAS TURNED ON TO INFUSE AT 10:27:32AM. THE CALCULATED TOTAL TIME FOR INFUSION IS 10 HOURS (T=V/R). THE INFUSION WAS THEN MANUALLY TURNED OFF AT 6:11:59PM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 38.7ML FOR DURATION OF 7 HOURS 44 MINUTES 27 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 100%. AT 6:12:10PM A NEW VTBI OF 100ML WAS ENTERED IN WITH THE PREVIOUSLY ENTERED RATE OF 5ML/HR. THE PUMP WAS TURNED ON TO INFUSE AT 6:12:13PM. THE CALCULATED TOTAL TIME FOR INFUSION IS 20 HOURS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 8:34:39PM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 11.86ML FOR DURATION OF 2 HOURS 22 MINUTES 26 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 100%. THE PUMP WAS TURNED ON TO INFUSE AT 9:28:44PM. THE REMAINING VOLUME TO BE INFUSED IS 88.14ML. THE CALCULATED TOTAL TIME FOR INFUSION IS 17 HOURS 37 MINUTES 41 SECONDS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 9:29:38PM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 0.08ML FOR DURATION OF 54 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 107%. PER THE USER'S MANUAL A DEVIATION OF +/- 5% IS ONLY GUARANTEED FOR INFUSIONS >2 MINUTES AT A RATE OF 25ML/H) OF THE EXPECTED VOLUME. THE PUMP WAS TURNED ON TO INFUSE AT 9:30:20PM. THE REMAINING VOLUME TO BE INFUSED IS 88.06ML. THE CALCULATED TOTAL TIME FOR INFUSION IS 17 HOURS 36 MINUTES 43 SECONDS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 1:21:14AM ON 11/22/2012. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 19.24ML FOR DURATION OF 3 HOURS 50 MINUTES 54 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 100%. THE PUMP WAS TURNED ON TO INFUSE AT 1:24:34AM. THE REMAINING VOLUME TO BE INFUSED IS 68.82ML. THE CALCULATED TOTAL TIME FOR INFUSION IS 13 HOURS 45 MINUTES 50 SECONDS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 9:45:29AM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 41.74ML FOR DURATION OF 8 HOURS 20 MINUTES 55 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 100%. THE PUMP WAS THEN TURNED OFF AT 9:45:39AM AND TURNED BACK ON AT 9:47:21AM. AT 9:47:40AM A NEW VTBI OF 90ML WAS ENTERED WITH THE PREVIOUSLY ENTERED IN RATE OF 5ML/HR. THE PUMP WAS TURNED ON TO INFUSE AT 9:47:41AM. THE CALCULATED TOTAL TIME FOR INFUSION IS 18 HOURS (T=V/R). AT 9:49:56AM AN UPSTREAM ALARM TURNED ON AND THE INFUSION AUTOMATICALLY STOPPED AT THE SAME TIME. THE ALARM WAS CONFIRMED AT 9:50:34AM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 0.19ML FOR DURATION OF 2 MINUTES 15 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 101%. THE PUMP WAS TURNED ON TO INFUSE AT 9:50:42AM. THE REMAINING VOLUME TO BE INFUSED IS 89.81ML. THE CALCULATED TOTAL TIME FOR INFUSION IS 17 HOURS 57 MINUTES 43 SECONDS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 12:17:58PM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 12.26ML FOR DURATION OF 2 HOURS 27 MINUTES 16 SECONDS. THE CALCULATED TIME FOR THIS VOLUME WAS 2 HOURS 27 MINUTES 7 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 100%. THE PUMP WAS TURNED ON TO INFUSE AT 12:18:25PM. THE REMAINING VOLUME TO BE INFUSED IS 77.55ML. THE CALCULATED TOTAL TIME FOR INFUSION IS 15 HOURS 30 MINUTES 36 SECONDS. THE INFUSION WAS THEN MANUALLY TURNED OFF AT 12:30:48PM. THE TOTAL VOLUME INFUSED FOR THIS TIMEFRAME WAS 1.04ML FOR DURATION OF 12 MINUTES 23 SECONDS. THE TOTAL AMOUNT INFUSED RELATIVE TO THE TIMEFRAME IS 101%. THE PUMP WAS THEN TURNED OFF AT 12:31:47PM AND WAS NOT USED THE REMAINDER OF THE DAY. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. BASED ON THE RESULTS OF INVESTIGATION, THIS THE PUMP OPERATED AS INTENDED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: OVER INFUSION. PATIENT OK. OVERINFUSION; AGE 78, MALE, 71.2 KILOGRAMS WEIGHT. RESPIRATORY CONDITION - VENTILATOR DEPENDENT, DRUG: FENTANYL. NO INJURY, AND NO MEDICAL INTERVENTION. LONG TERM ACUTE CARE AREA, CONTINUOUS THERAPY. DATE OCCURRED: (B)(6) 2012. RAN (B)(6). RATE 50 MICROGRAMS/HR - VOL 1,000 IN 100 ML (BAG 1/2 GONE), 1/2 BAG RUN 9:40AM TO NOON, AND AT NOON NOTICED BAG 1/2 EMPTY, RETURNED AND LOCKED IN MATERIAL MANAGEMENT DEPT - 50 MIL LEFT SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599249 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other