BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 11664374 · Received April 14, 2021

    Report

    Report Number
    9610825-2021-00121
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 21, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT #: (B)(4). SAMPLE/S EVALUATION: IN PROCESS AND FINAL CONTROL FLOW RATE REPORTS WERE TAKEN INTO ANALYSIS. FOR IN PROCESS FLOW RATE (BEFORE ETO) REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN -6.99% AND 3.41%. FOR FINAL CONTROL FLOW RATE (AFTER ETO) REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN 1.02% AND 6.87%. THE FLOW RATE RESULTS WERE WITHIN SPECIFICATION. NO ABNORMALITIES WERE FOUND FROM THE FLOW RATE REPORTS. SAMPLE/S EVALUATION: NO COMPLAINT SAMPLE OR PICTURE IS AVAILABLE FOR INVESTIGATION. ROOT CAUSE ANALYSIS: AS NEITHER COMPLAINT SAMPLE NOR PICTURE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE. HOWEVER, THERE ARE SOME POSSIBILITIES THAT CAN CAUSE THE SAMPLE EMPTIES FASTER THAN NOMINAL TIME IN ACTUAL APPLICATION, SUCH AS ONE OR COMBINATION FACTORS OF MORE THAN ONE AS BELOW: FACTOR 1 TEMPERATURE: THE TEMPERATURE OF THE SURROUNDING WILL AFFECT THE FLOW RATE OF THE SAMPLE. FOR EVERY INCREASE OF 1°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE APPROXIMATELY BY 3%. FOR EXAMPLE, IF THE FLOW RESTRICTOR OF THE PRODUCT REACHES THE TEMPERATURE OF 37°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE BY APPROXIMATELY 18% WHICH MEANS THE FLOW RATE WILL INCREASE FROM 5ML/HR TO 5.9ML/HR. FACTOR 2 EXTERNAL PRESSURE: EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE WHICH CAUSE THE PUMP TO EMPTY EARLIER THAN THE NOMINAL TIME. SIMULATION OF EXTERNAL PRESSURE HAD BEEN CONDUCTED. THE FLOW RATE OF THE PRODUCT CAN INCREASE WHEN EXTERNAL FORCE IS APPLIED TO THE PUMP. HOWEVER, THIS EXTERNAL FORCE IS AGAINST THE INTENDED USE OF THE PRODUCT ACCORDING TO IFU. FACTOR 3 FOLDED BLOW MOLD: FOLDED BLOW MOLD WILL ALSO ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. SUMMARY OF ROOT CAUSE ANALYSIS: AS NEITHER COMPLAINT SAMPLE NOR PICTURE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE. THEREFORE, THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. HOWEVER, CONFIRMED FLOW RATE ISSUE IS ADDRESSED TO CAPA. CAUSE: CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # 400507969: A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS INVESTIGATION 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 · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): WRONG TIME. CUSTOMER REPORTED: FEMALE PATIENT IN THE FIFTH DECADE OF LIFE WHO HAS A DIAGNOSIS OF MALIGNANT COLON TUMOR AND IS UNDERGOING PHARMACOLOGICAL TREATMENT WITH FOLFOX PROTOCOL; ON (B)(6) 2021 THE PATIENT RECEIVES THE PHARMACOLOGICAL TREATMENT WITHIN THE INSTITUTION, STARTING WITH THE COUPLING OF THE ELASTOMERIC PUMP FOR 46 HOURS OF INFUSION WITH 5-FLUOROURACIL ON THE SAME DAY IN THE MIDDLE OF THE DAY; THE PATIENT RETURNS TO THE INSTITUTION ON (B)(6) 2021 FOR THE REMOVAL OF THE ELASTOMERIC PUMP, AT THAT TIME THE PATIENT REPORTS THAT THE MEDICAL DEVICE FINISHED ITS INFUSION THE PREVIOUS DAY IN THE AFTERNOON, APPROXIMATELY AT 06: 00 PM (AN APPROXIMATE TIME OF 30 TOTAL HOURS OF INFUSION); THE PHARMACEUTICAL SERVICE CHECKS THE ELASTOMERIC PUMP WITHOUT FINDING ANY ALTERATION ON IT. THE PATIENT IS A LITTLE UNWELL DUE TO SECONDARY EVENTS TO THE PHARMACOLOGICAL TREATMENT AND HYDRATION IS PERFORMED BY GENERAL MEDICINE. THE ADMINISTRATION OF LIQUIDS IN THE INSTITUTION IS COMPLETED, WITH IMPROVEMENTS FROM THE PHYSIOLOGICAL POINT OF VIEW BY GENERAL MEDICINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564381 EASYPUMP PUMP, INFUSION, ELASTOMERIC MEB B. BRAUN MELSUNGEN AG 20F19GE271

    Patients

    Seq Age Sex Outcome Treatment
    1