BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 21825465 · Received April 11, 2025

    Report

    Report Number
    9610825-2025-00248
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    April 3, 2025
    Report Date
    June 25, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER: (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER: (B)(4). PREMARKET SUBMISSION#: K083689, K142596, K191910.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K083689, K142596, K191910. ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER. ANALYSIS OF USE HISTORY THE LAST PROGRAMMING AND INFUSION RECORDED IN THE EQUIPMENT'S USAGE HISTORY WAS ON 04/10/2025. THE USER PROGRAMMED THE FLOW RATE TO BE 250ML/H AND THE VOLUME TO BE 1000ML. THE INFUSION STARTED AT 14:52:47 AND STOPPED AT 14:54:12. THE TOTAL VOLUME INFUSED WAS 5.92ML, PROPORTIONAL TO THE PROGRAMMING AND USER ACTIONS. WE DID NOT FIND ANY OCCURRENCE OF FREE FLOW. WE EVIDENCED IN THE HISTORY THE PCA PROGRAMMING ON 04/02/2025. PCA XH-LIM.SET 84ML; PCA VOL/AM.SET 7ML; DATALOCK MODE 3; PCA LIMIT TIME 4H; DRUG SHORT NAME ROPIVAC; PCA LOCKOUT SET 00:20 HH:MM; RATE SET 2.5ML/H; TYPE NBR OF THERAPY 4; TYPE OF THERAPY PCA. THE PROGRAMMING WAS STARTED AT 18:17:44 ON 04/02/2025 AND WAS STOPPED AT 07:49:23 ON 04/03/2025. THE INFUSED VOLUME WAS 0.3ML. THE PROGRAM WAS STARTED AT 08:20:42 ON 04/03/2025 AND WAS STOPPED AT 13:05:46 ON 04/03/2025. THE TOTAL VOLUME INFUSED CONTINUED TO BE 0.3 ML. THERE IS NO EVIDENCE OF FREE-FLOW INFUSION. FUNCTIONAL ANALYSIS START/STOP FUNCTION TEST. DURING THERAPY, WE STOPPED THE INFUSION BY PRESSING START/STOP. THE AIM WAS TO CHECK WHETHER THE INFUSION WOULD STOP OR WHETHER IT WOULD CONTINUE TO DRIP FREELY. THE INFUSION STOPPED AND THERE WAS NO DRIPPING. RESULT: APPROVED STANDBY FUNCTION TEST. USING THE LAST PROGRAMMING RECORDED IN THE EQUIPMENT'S USAGE HISTORY, WE PROGRAMMED THE VOLUME OF 1000ML AND THE FLOW RATE OF 250ML/H, STARTED THE INFUSION AND STOPPED IT USING THE STANDBY FUNCTION. WHEN THE INFUSED VOLUME WAS APPROXIMATELY 6ML, WE STOPPED THE INFUSION AND ACTIVATED THE STANDBY FUNCTION. THE EQUIPMENT REMAINED IN STANDBY FOR 14H19MIN. THE OBJECTIVE WAS TO CHECK WHETHER THE INFUSION WOULD STOP OR IF IT WOULD CONTINUE TO DRIP IN FREE FLOW. THE INFUSION STOPPED AND THERE WAS NO DRIPPING. RESULT: APPROVED VISUAL ANALYSIS EQUIPMENT APPEARS NORMAL AS USED. IN THE ANALYSIS OF THE USAGE HISTORY, WE DID NOT FIND ANY RECORD OF FREE FLOW OR ERROR IN THE INFUSION TIME OR INFUSED VOLUME. IN THE FUNCTIONAL TESTS, WE DID NOT FIND ANY OCCURRENCE OF FREE FLOW OR INFUSION ERROR IN ANY OF THE TESTS PERFORMED. EQUIPMENT IS WORKING CORRECTLY AND ACCURATELY. FREE FLOW TECHNICAL COMPLAINT NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "PATIENT IN THE POSTOPERATIVE PERIOD OF SPINAL SURGERY, EPIDURAL CATHETER INSTALLED FOR POSTOPERATIVE ANESTHESIA AND CONNECTED TO THE PATIENT-CONTROLLED ANALGESIA PUMP. IN THE PERIOD OF 12 HOURS, THE 250ML SOLUTION WAS INFUSED WITHOUT THE PATIENT HAVING ACTIVATED THE PUMP. THERE WAS NO RECORD OF ACTIVATION OR CONTINUOUS INFUSION. WHEN REMOVING THE CATHETER AND DISCONNECTING THE SET, I NOTICED THAT IT CONTINUED TO DRIP EVEN WITH THE PUMP ON STANDBY. THE EVENT OCCURRED ONCE AND WAS VERIFIED BY THE ANESTHESIOLOGIST. AFTER IDENTIFYING THE PROBLEM, THE CATHETER WAS REMOVED. TREATMENT STARTED ON (B)(6) 2025 AND ENDED ON (B)(6) 2025. THE EVENT WAS CONSIDERED SERIOUS BY THE CLIENT, PROLONGED HOSPITALIZATION BY 1 DAY AND GENERATED PROLONGED MOTOR BLOCK. EVENT TREATMENT: CATHETER REMOVED WITH COMPLETE RECOVERY OF MOTOR BLOCK. PATIENT RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269665 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female