BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURETTE SETS 150 ML.

    MDR report key: 12240143 · Received July 28, 2021

    Report

    Report Number
    2243072-2021-01971
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    March 12, 2020
    Report Date
    August 19, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT #: 20200917. H.6. INVESTIGATION: A DFP-87-FH PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20200917. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT APPEARS THAT THE BLUE FLOAT VALVE WOULDN'T FLOAT, WHICH RESULTED IN AN OCCLUSION. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, ANHUI TIANKANG MEDICAL PRODUCTS CO.,LTD, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 20200917 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BURETTE SETS 150 ML. DREW AIR INTO THE EMPTY CHAMBER ONCE DISCONNECTED FROM THE DOSIFIX SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "SOMETIMES A VACUUM IS CREATED IN THE SYSTEM SO THAT THE BLUE FLOAT CAN NO LONGER LIFT ITSELF AND THE SYSTEM HAS TO BE DISCONNECTED. IN ADDITION, IT OFTEN DRAWS IN AIR ONCE THE CHAMBER IS EMPTY. POTENTIALLY SERIOUS. PATIENT WAS NOT HARMED AS THE USERS CLOSELY MONITORED THE SITUATION. DOSIFIX REPEATEDLY FORMED A VACUUM WHILE IT WAS CONNECTED TO THE PATIENT, WHICH HAD TO BE CORRECTED AND AIR HAD TO BE DRAWN IN SEVERAL TIMES. WITHOUT CONSTANT INTERVENTION, THIS WOULD HAVE LED TO AIR EMBOLISM."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # 20200917 WAS NOT FOUND FOR THE REPORTED CATALOG # DFP-87-FH. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURETTE SETS 150 ML. DREW AIR INTO THE EMPTY CHAMBER ONCE DISCONNECTED FROM THE DOSIFIX SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "SOMETIMES A VACUUM IS CREATED IN THE SYSTEM SO THAT THE BLUE FLOAT CAN NO LONGER LIFT ITSELF AND THE SYSTEM HAS TO BE DISCONNECTED. IN ADDITION, IT OFTEN DRAWS IN AIR ONCE THE CHAMBER IS EMPTY. POTENTIALLY SERIOUS. PATIENT WAS NOT HARMED AS THE USERS CLOSELY MONITORED THE SITUATION. DOSIFIX REPEATEDLY FORMED A VACUUM WHILE IT WAS CONNECTED TO THE PATIENT, WHICH HAD TO BE CORRECTED AND AIR HAD TO BE DRAWN IN SEVERAL TIMES. WITHOUT CONSTANT INTERVENTION, THIS WOULD HAVE LED TO AIR EMBOLISM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135125 BURETTE SETS 150 ML. INTRAVASCULAR ADMINISTRATION SET FPA 20200917

    Patients

    Seq Age Sex Outcome Treatment
    1