BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5061153 · Received September 8, 2015

    Report

    Report Number
    9610825-2015-00376
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 19, 2015
    Report Date
    May 7, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS BEING SUBMITTED RETROSPECTIVELY DUE TO A FILING ERROR BY B. BRAUN MEDICAL INC. AT THE TIME OF THE REPORTING. AT THE TIME OF FOLLOW-UP REPORTING, EXEMPTION E2011009 APPLIED TO THE CASE. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). RESULT OF EXAMINATION: THE PROVIDED SAMPLE WAS SUBJECTED TO A VISUAL EXAMINATION. THE DEVICE WAS CONTAMINATED. THE UPPER HOUSING WAS FOUND SLIGHTLY BENDED UP - RIGHT ABOVE THE SAFETY CLAMP. THE EMERGENCY RELEASE PLUG SHOWED MARKS OF IMPROPER USE. THE OPENING LEVER FOR THE SAFETY CLAMP SHOWED SIGNS OF A BALL-PEN. TOGETHER WITH THE DEVICE AN INSERTED LINE WAS DELIVERED. SHORTLY AFTER THE DEVICE PASSED THE SELF TEST WITH A POSITIVE IT REPORTED "DEFECT LINE" AN OPENING OF THE FRONT AS WELL AS A START-UP WAS NOT POSSIBLE. THEREUPON THE SAMPLE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE CLEARLY SIGNS OF A DROP DOWN WERE FOUND. THE DOOR BOLT DRIVE WAS CRANKED UNTIL LIMIT STOP. THIS CAUSED A BENT DOOR BOLT AND THE MECHANIC OF THE DOOR BOLT WAS TWISTED. THE CHASSIS SUFFERED A DAMAGED OF ITS PLASTIC. DUE TO THE FOUND DAMAGES, A FUNCTIONAL TEST WAS NOT PERFORMED. OCCURRENCE OF DEVICE ALARMS COULD NOT BE EXCLUDED. NO CONCLUSION CAN BE MADE REGARDING THIS 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. IN CASE HIGH POTENT DRUGS ARE GIVEN BE SURE TO HAVE A SECOND INFUSION PUMP FOR THAT DRUG AT HAND. THE THERAPY DOCUMENTATION SHOULD BE SUITABLE TO CONTINUE THE THERAPY AT THE SECOND INFUSION PUMP. DEVICE ALARMS: WHEN A DEVICE ALARM OCCURS THE INFUSION IS IMMEDIATELY STOPPED. SWITCH OFF THE DEVICE. THEN SWITCH THE DEVICE ON AGAIN. IN CASE OF A REPEATED DEVICE ALARM YOU MUST CLOSE THE ROLLERCLAMP, DISCONNECT FROM THE PATIENT, OPEN THE FRONT DOOR OF THE PUMP AND TAKE OUT THE DISPOSABLE. THE DEVICE NEEDS TO BE HANDED TO THE SERVICE DEPARTMENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): DRUG ADMINISTRATION STOPPED CYTOSTATIC DRUG ADMINISTRATION STOPPED/PAUSED, TUBING JAMMED INSIDE THE PUMP. "THE PATIENT RANG THE ALARM BELL AS THE INFUSION PUMP HAD A "LOUD NOISE." THE PUMP GAVE A "DEVICE ALARM." THE NURSE SWITCHED OFF THE PUMP AND TRIED TO OPEN THE DOOR IN ORDER TO SWITCH THE TUBING INTO ANOTHER PUMP. THE DOOR DID HOWEVER NOT OPEN AT ALL. A TECHNICIAN WAS CALLED FOR ASSISTANCE BUT NEITHER HE MANAGED TO OPEN THE DOOR. ALSO THE LOCAL B. BRAUN REPRESENTATIVE WAS CONSULTED. THE PHYSICIAN IN CHARGE WAS INFORMED THAT THE ADMINISTERED CYTOSTATIC DRUG WAS ALMOST FINISHED, ONLY THE FLUSHING OF THE TUBING WAS LEFT. AS THE TUBING HOWEVER COULD NOT BE DETACHED, 20 MILLILITER OF THE DRUG COULD NOT BE ADMINISTERED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593741 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1