BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3111453 · Received April 12, 2013

    Report

    Report Number
    9610825-2013-00092
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    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 MANUFACTURER), AND (B)(4) (THE IMPORTER). (B)(4). THE PUMP HAS SOFTWARE VERSION 686G030102. THE PUMP WAS TESTED THREE TIMES FOR VOLUMETRIC ACCURACY WITH A RATE OF 390ML/HR AND A VOLUME TO BE INFUSED 130ML WITH RESULTS AS FOLLOWS: FIRST TEST: 131ML OR 101% OF EXPECTED VOLUME IN 20 MINUTES. SECOND TEST: 133ML OR 102% OF EXPECTED VOLUME IN 20 MINUTES. THIRD TEST: 133ML OR 102% OF EXPECTED VOLUME IN 20 MINUTES. THE PUMP OPERATED WITHIN SPECIFICATIONS. IT WAS NOTED WHEN THE PUMP WAS RECEIVED THAT THE PUMP HAD A LOCKED SAFETY CLAMP (SHUT) WITH DOOR OPEN WHICH IS CAUSED WHEN THE DOOR IS NOT PRESSED PROPERLY TO CLOSE. THE 'DOOR OPEN/CLOSE' WAS RECYCLED TO CORRECT. ELECTRONIC AND MECHANICAL OCCLUSION PRESSURE AND SAFETY CLAMP TEST WERE PERFORMED AND WERE WITHIN SPECIFICATION. IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INJURY. SHE STATED THAT THE DATE OF OCCURRENCE WAS (B)(6) 2013 AND THAT DEXAMETHASONE WAS BEING INFUSED: 120ML AT 400ML/HR. SHE STATED THAT THEY HAD JUST RECENTLY STARTED USING THE PUMPS IN THEIR FACILITY. FOR THIS INCIDENT, SHE NOTED THAT THEY HAD DIFFICULTY REMOVING THE TUBING FROM THE PUMP. THE REPORTER THEN STATED THAT THEY HAD RECEIVED THE PUMP BACK AND REVIEWED THE SERVICE REPORT. THE SERVICE REPORT INDICATED THAT THE PUMP HAD A LOCKED SAFETY CLAMP (SHUT) WITH DOOR OPEN WHICH IS CAUSED WHEN THE DOOR IS NOT PRESSED PROPERLY TO CLOSE. THE REPORTER THEN STATED THAT THE EVENT MOST LIKELY WAS A RESULT OF THE PUMPS BEING NEW TO THEIR FACILITY AND THEY WERE NOT VERY FAMILIAR WITH THE PUMPS. WHEN ASKED IF SHE WOULD LIKE TO HAVE ADDITIONAL SUPPORT OR TRAINING FROM A B.BRAUN REPRESENTATIVE, SHE DECLINED AND DID NOT THINK IT WAS NECESSARY AT THIS TIME. THE PUMP'S OPERATIONAL LOG WAS REVIEWED. ON (B)(6) 2013 AT 5:23:00 PM THE PUMP WAS TURNED ON. AT 5:24:25 PM A NEW THERAPY WAS SELECTED, THEN NEW VTBI (VOLUME TO BE INFUSED) AND RATE WERE OF 100ML AND 100ML/H RESPECTIVELY. AT 5:24:32 PM THE INFUSION WAS STARTED. THE INFUSION WAS STOPPED AT 5:47:08 PM WITH A TOTAL OF 37.65ML INFUSED OR 100% OF EXPECTED VOLUME. AT 5:47:11 THE NEW THERAPY WAS SELECTED. A NEW VTBI AND RATE WERE SET TO 165ML AND 330ML/H RESPECTIVELY. AT 5:47:27 PM THE INFUSION WAS STARTED. THE PUMP RAN UNTIL 6:17:28 PM, WHEN THE INFUSION COMPLETED AND THE PUMP AUTOMATICALLY SWITCHED INTO KVO (KEEP VEIN OPEN) MODE. A TOTAL OF 165ML INFUSED OR 100% OF EXPECTED VOLUME. THE KVO MODE WAS STOPPED AT 6:18:09PM. AT 6:18:14 PM A NEW TIME WAS SET TO 10 MINUTES. AT 6:18:15 PM THE INFUSION WAS RESTARTED AT THE SAME RATE OF 330ML/H. THE INFUSION WAS STOPPED AT 6:20:24 PM WITH A TOTAL OF 11.83ML INFUSED OR 100% OF EXPECTED VOLUME. THE PUMP WAS TURNED OFF AT 6:20:41 PM. AT 9:56:28 PM THE PUMP WAS TURNED BACK ON. A NEW THERAPY WAS SET AT 9:58:07 PM. A NEW VTBI AND RATE WERE THEN SET TO 200 ML AND 100 ML/H RESPECTIVELY. AT 9:58:14 THE INFUSION WAS STARTED. THE PUMP WAS STOPPED AT 10:01:46 PM WITH A TOTAL OF 5.84ML INFUSED OR 99% OF EXPECTED VOLUME. AT 10:01:47PM THE NEW THERAPY WAS SELECTED. AT 10:01:53PM A NEW VTBI AND RATE WERE THEN SET TO 130 AND 390ML/H RESPECTIVELY. THE TIME WAS SET TO 20 MINUTES. THE INFUSION WAS STARTED AT 10:01:59PM. THE PUMP RAN UNTIL 10:21:59 WHEN THE INFUSION WAS COMPLETED AND THE PUMP AUTOMATICALLY SWITCHED INTO KVO MODE. A TOTAL OF A 130ML INFUSED OR 100% OF EXPECTED VOLUME. THE KVO MODE WAS STOPPED AT 10:22:07. THE PUMP WAS NOT USED FOR THE REST OF THE DAY AND WAS TURNED OFF AT 10:39:36PM. BASED ON THE RESULTS OF THIS INVESTIGATION, THE PUMP OPERATED AS INTENDED. NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER, IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REFERENCE IMPORTER NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158926 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1