BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2360034 · Received November 22, 2011

    Report

    Report Number
    9610825-2011-00169
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 12, 2011
    Report Date
    November 22, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). AN ON-SITE ANALYSIS WAS CONDUCTED FOR THIS PUMP BY A B. BRAUN INFUSION SYSTEMS SPECIALIST WITH THE FACILITY'S BIOMEDICAL DIRECTOR. THE PUMP, TUBING, AND SOLUTION WERE ALL CONTAINED TOGETHER WITH THE TUBING STILL IN THE DEVICE. UPON OPENING THE PUMP DOOR, IT WAS OBSERVED THAT THE SET BASED ANTI FREE FLOW CLIP WAS IN THE OPEN POSITION AND ONLY PARTIALLY INSERTED INTO THE PUMP'S CLIP CHANNEL. BECAUSE THE ANTI FREE FLOW CLIP WAS NOT FULLY INSERTED INTO THE CLIP CHANNEL, THE PUMP BASED FREE FLOW PROTECTION WAS NOT ENGAGED. PROPER TUBING INSERTION TECHNIQUE WAS DEMONSTRATED TO THE FACILITIES BIOMEDICAL DIRECTOR, AND THE PUMP DID NOT FREE FLOW. THE TUBING WAS THEN IMPROPERLY INSERTED, MIMICKING HOW THE SET WAS OBSERVED TO BE MISLOADED. IT WAS CONFIRMED THAT THE PUMP SCREEN PROMPTED 'KEEP ROLLER CLAMP CLOSED' AND THE PUMP PROCEEDED THROUGH IT'S SELF CHECK. DURING THE SELF TEST, THE PUMP ALARMED 'INVALID LINE' AND IF THE ROLLER CLAMP WAS OPENED, THE PUMP FREE FLOWED. IT SHOULD BE NOTED THAT WHEN THE SET BASED ANTI FREE FLOW CLIP IS NOT INSERTED IN THE CLIP CHANNEL, THE WARNING LIGHT WHICH IS PRESENT INSIDE THE PUMP REMAINS ILLUMINATED. THIS WARNING LIGHT ONLY TURNS OFF ONCE THE IV SET ANTI FREE FLOW CLIP IS PROPERLY POSITIONED IN THE CLIP CHANNEL IN THE PUMP. VISUAL INSPECTION OF THE PUMP DOOR IDENTIFIED THAT THE PUMP'S FREE FLOW CLIP CATCH WAS BROKEN. IF THE CLIP CATCH HAD NOT BEEN BROKEN, CLOSING THE PUMP DOOR WOULD HAVE FORCED THE SET BASED ANTI FREE FLOW CLIP INTO IT'S PROPER POSITION. BROKEN CLIP CATCHES ARE TYPICALLY THE RESULT OF IMPROPER INSERTION OF THE IV SET BASED ANTI FREE FLOW CLIP. IF THE SET BASED ANTI FREE FLOW CLIP IS NOT PLACED INTO IT'S CORRECT POSITION, AND TH FRONT DOOR OF THE PUMP IS FORCED CLOSED BY THE USER, THE CLIP CATCH CAN BREAK. IT SHOULD BE NOTED THERE ARE SEVERAL MITIGATING MECHANISMS BETWEEN THE PUMP AND THE TUBING SET THAT PREVENT FREE FLOW WHEN THE PUMP IS NOT RUNNING. ADHERENCE TO THE IFU BY THE USER MITIGATES RISK OF POTENTIAL FREE FLOW SHOULD THE CLIP CATCH BE BROKEN. THE RESULTS OF THE ON-SITE ANALYSIS WERE REVIEWED WITH THE FACILITIES RISK MANAGER AND BIOMEDICAL DOCTOR. BOTH PARTIES AGREED THAT THE RN DID NOT FOLLOW THE INSTRUCTIONS FOR USE WHEN IMPROPERLY INSERTING THE TUBING AND FAILED TO CLOSE THE ROLLER CLAMP, THUS CREATING THE CONDITION FOR FREE FLOW. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE FROM THE MANUFACTURER, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: B. BRAUN PUMP FAILED, TUBING PRIMED WITH DOOR CLOSED WITH A MESSAGE "INVALID LINE CHECK" ON STANDBY BUT THE IV WAS RUNNING WIDE OPEN. IV INFUSION IMMEDIATELY DISCONNECTED FROM PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATES THE NURSE PRIMED THE SET AND LOADED THE TUBING. SHE CLOSES DOOR. PUMP ALARMS PRODUCING MESSAGE INDICATING "INVALID LINE." CLINICIAN OBSERVES FREE FLOW. CLINICIAN PULLS PUMP IMMEDIATELY FROM SERVICE AND SENDS TO BIOMEDICAL ENGINEERING.

    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 UNKNOWN Other