BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWING BREAST PUMP

    MDR report key: 2231229 · Received August 26, 2011

    Report

    Report Number
    1419937-2011-00181
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. THOUGH MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL COMPLAINT INFORMATION AND MEDICAL TREATMENT RECEIVED, IF ANY, THEY WERE UNSUCCESSFUL. IN ONE OF THE FOLLOW UP ATTEMPTS, CONTACT WAS MADE WITH THE CUSTOMER'S MOTHER WHO INDICATED THAT THE CUSTOMER DID RECEIVED MEDICAL TREATMENT FOR HER MASTITIS WHICH HAS RESOLVED AND THE CUSTOMER HAS RECOVERED. SHE ALSO STATED THAT THE CUSTOMER IS USING THE REPLACEMENT PUMP AND IS DOING WELL WITH IT. "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." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. THE BREAST PUMP WAS RETURNED BY THE CUSTOMER FOR TESTING/ANALYSIS. IN SUMMARY, THE PUMP FAILED TO PERFORM ITS INTENDED FUNCTION AND DID NOT MEET ALL OF ITS PERFORMANCE SPECIFICATIONS. THE PUMP'S VACUUM LEVELS WERE ALL LOW IN COMPARISON TO SPECIFICATION AND THE PUMP DID NOT CYCLE AT MINIMUM SETTING IN BOTH STIMULATION AND EXPRESSION MODES. THOUGH THE PUMP DID NOT MEET ITS PERFORMANCE SPECIFICATIONS AND PRODUCED LOW VACUUM, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THIS CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. EVALUATION SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: SWING. AC ADAPTER MEDELA PART #9200043 (VOLTAGE WAS TESTED; THE TRANSFORMER FUNCTIONED PROPERLY AND WITHIN SPEC). TUBING (WAS RETURNED DAMAGED; AN ADAPTER WAS MISSING AND THE TUBING COULD NOT BE USED FOR THE EXPERIMENT). VACUUM LEVELS AND CYCLE RATES WERE MEASURED. THE FOLLOWING DATA POINTS WERE OUT OF SPECIFICATION: MINIMUM VACUUM LEVEL IN STIMULATION MODE - LOW. MAXIMUM VACUUM LEVEL IN STIMULATION MODE - LOW. MINIMUM VACUUM LEVEL IN EXPRESSION MODE - LOW. MAXIMUM VACUUM LEVEL IN EXPRESSION MODE - LOW. THE PUMP DID NOT CYCLE IN BOTH STIMULATION AND EXPRESSION MODES (AT MINIMUM SETTING). NOTE 1 - VACUUM AND CYCLE RATES WERE MEASURED USING MEDELA PART NUMBER 700.2020 - VACUUM/CYCLE FIXTURE (ID# 3058); CALIBRATED DAILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT WHEN SHE RECEIVED HER BREAST PUMP, THE BREAST SHIELD WAS CRACKED. SHE USED THE PUMP WITH THE CRACKED SHIELD AND MILK BACKED UP INTO THE TUBING AND MOTOR. SHE CLEANED OUT THE MILK AND THE PUMP'S SUCTION HAS SLOWLY DECREASED. SHE BELIEVES THAT SHE HAS HAD MASTITIS AND LOSS OF MILK DUE TO ISSUES WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWING BREAST PUMP HGX MEDELA AG 67050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other