BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 2133408 · Received June 15, 2011

    Report

    Report Number
    1419937-2011-00135
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SVC SENT A REPLACEMENT PUMP TO THE CUSTOMER. WHEN IN CONTACT WITH THE CUSTOMER TO GET ADD'L COMPLAINT INFO AND TO PERFORM CLINICAL ASSESSMENT, INCLUDING A DETERMINATION OF WHAT MED TREATMENT, IF ANY, WAS REQUIRED, THE CUSTOMER WAS NOT FORTHCOMING WITH INFO. SHE INDICATED THAT SHE HAD CLOGGED DUCTS THAT PROGRESSED TO MASTITIS FOR WHICH SHE REC'D TREATMENT FROM AN (B)(6), BUT SHE DID NOT GIVE SPECIFICS ON THE TREATMENT REC'D. SHE IS NO LONGER USING A MEDELA PUMP, BUT SHE IS STILL EXPERIENCING CLOGGED DUCTS. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION, WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT. THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS." THE BREAST PUMP WAS RETURNED BY THE CUSTOMER FOR TESTING/ANALYSIS. ADD'L ANALYSIS OF THE PUMP'S TEST PERFORMANCE RESULTS IS REQUIRED BEFORE A FINAL DETERMINATION CAN BE MADE REGARDING ITS POSSIBLE EFFECT ON THE END USER. BASED ON THE FACT THAT THE CUSTOMER DISCONTINUED USE OF THE PUMP BUT STILL EXPERIENCES CLOGGED DUCTS, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. EVAL SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: FREESTYLE. AC ADAPTER MEDELA PART #9207047 (THE TRANSFORMER WAS RETURNED AND WAS IN PROPER WORKING ORDER). VACUUM LEVELS AND CYCLE RATES WERE MEASURED AND THE FOLLOWING WERE THE RESULTS (NOTE: THE PUMP RAN FOR 30 SECONDS BEFORE ANY MEASUREMENTS WERE TAKEN). THIS PUMP DOES NOT MEET PASS CRITERIA FOR TEST # TS.6 WHICH CAN BE FOUND IN THE FREESTYLE DESIGN HISTORY FILE. TEST # TS.6 STATES THAT SINGLE PUMP VACUUM SHOULD BE, FOR STIMULATION MODE: DOUBLE PUMPING VACUUM +40MMHG/-20MMHG AND SINGLE PUMP VACUUM SHOULD BE FOR EXPRESSION MODE: DOUBLE PUMPING VACUUM +20MMHG/-30MMHG. ADD'L ANALYSIS OF THE PUMP'S TEST PERFORMANCE RESULTS IS REQUIRED BEFORE A FINAL DETERMINATION CAN BE MADE REGARDING ITS POSSIBLE EFFECT ON THE END USER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SVC THAT SHE HAS CLOGGED DUCTS AND WAS DIAGNOSED WITH MASTITIS. SHE WAS ADVISED BY HER LACTATION CONSULTANT THAT IT WAS CAUSED BY HER BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BREAST PUMP HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention