BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 19135683 · Received April 18, 2024

    Report

    Report Number
    9610825-2024-00274
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 20, 2024
    Report Date
    July 3, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. DHR REVIEWED: DEVICE HISTORY RECORD (DHR):- REVIEWED THE DHR FOR BATCH 23G15GED71, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION. SAMPLE/S EVALUATION: RECEIVED ONE SAMPLE OF EASYPUMP II LT 400-40-S-EU/SA WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, THE SAMPLE WAS CLAMPED, SOME WATER WAS FILLED, OUTER SLEEVE ATTACHED WITH ADHESIVE TAPE AND THE RED COMBI STOPPER WAS ATTACHED. ANALYSIS: UPON VISUAL INSPECTION, CRACK WAS OBSERVED AT FILLING PORT OF COMPLAINT SAMPLE. CRACK AT THE FILLING PORT IS A KNOWN ISSUE AND ADDRESSED IN BOTH BY APPROVED PROJECTS. ACTIONS HAVE BEEN TAKEN TO MINIMIZE THIS DEFECT. AFFECTED BATCHES OF CAP VALVE USED IN THE COMPLAINT SAMPLE BATCH (23G15GED71) BELOW: MATERIAL MATERIAL SHORT TEXT BATCH 483SFGM1100007 CAP VALVE (B)(6). 483SFGM1100007 CAP VALVE (B)(6). 483SFGM1100007 CAP VALVE (B)(6). AFFECTED CAP VALVE CAVITY NUMBER AS BELOW: ITEM CAVITY NUMBER; CAP VALVE OF THE SAMPLE A5. THE ADHESIVE TAPE WAS REMOVED FROM THE OUTER SLEEVE, NO ABNORMALITY WAS OBSERVED AT THE PVC PUNCH HOLE. THIS HOLE IS AN INTENDED DESIGN TO ALLOW AIR TO ESCAPE BETWEEN THE SILICONE ELASTOMERIC MEMBRANE AND THE OUTER SHELL DURING FILLING. FURTHER INVESTIGATION WAS CONDUCTED TO CONFIRM THE COMPLAINT LEAKAGE. THE COMPLAINT SAMPLE WAS UNCLAMPED, AND THE SOLUTION FLOWED OUT IMMEDIATELY. NO LEAKAGE WAS OBSERVED FROM VALVE AREA, SILICONE SLEEVE, FILTER AND TUBE CONNECTION. SUMMARY OF ROOT CAUSE ANALYSIS: NO LEAKAGE NOR ABNORMALITY WAS OBSERVED ON COMPLAINT SAMPLE. HENCE, WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED.

    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. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT, ON (B)(6) 2024 AT 12:45, THE PATIENT STARTED FLUOROURACIL (5FU) (4000 MILLIGRAM (MG) PER MILLILITER (ML)) CHEMOTHERAPY TREATMENT. SUBSEQUENTLY, THE PATIENT WAS DISCHARGED TO HOME CARE EQUIPPED WITH THE PORTABLE ELASTOMERIC PUMP. HOWEVER, AT APPROXIMATELY 16:00 ON THE SAME DAY, THE PATIENT REPORTED AN AUDIBLE "WHEEZING" COMING FROM THE DEVICE. UPON FURTHER INSPECTION, A HOLE WAS IDENTIFIED IN THE DEVICE, WHICH WAS TEMPORARILY SEALED WITH DUCT TAPE. THE PATIENT RETURNED TO THE HOSPITAL AROUND 18:00, AND THE PORTABLE ELASTOMERIC PUMP WAS DISCONNECTED FROM THE PATIENT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606965 EASYPUMP 2 ELASTOMERIC PUMPS MEB B BRAUN MELSUNGEN AG 4540014-07 23G15GED71

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown