BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2050775 · Received March 31, 2011

    Report

    Report Number
    1419937-2011-00056
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. DURING A CLINICAL ASSESSMENT OF THE COMPLAINT, THE CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION. THE CUSTOMER INDICATED THAT SHE BEGAN USING THE BREAST PUMP ON (B)(6) 2011; PRIOR TO THAT, SHE HAD BEEN EXCLUSIVELY BREAST FEEDING HER BABY FOR ONE MONTH. SHE NOTICED THAT THE MOTOR SOUNDED LIKE IT WOULD TURN OFF AND ON AND HER NIPPLES WERE SORE AFTER PUMPING. SHE USED THE PUMP FOR TWO DAYS BUT, BECAUSE, HER NIPPLES WERE SORE, SHE DID NOT USE THE PUMP AGAIN, AND CONTINUED TO EXCLUSIVELY BREAST FEED. ON (B)(6) 2011, SHE VISITED HER OBGYN, WHO DIAGNOSED HER WITH MASTITIS AND PRESCRIBED AN ANTIBIOTIC, WHICH RESOLVED THE MASTITIS. SHE VISITED A LACTATION CONSULTANT AS SUGGESTED BY THE DOCTOR. THE LACTATION CONSULTANT SAID, THE PUMP'S VACUUM WAS LOW AND FOUND THAT THE BREAST SHIELDS THAT THE CUSTOMER WAS USING WERE TOO SMALL. THE BREAST PUMP WAS RETURNED BY THE CUSTOMER AND IT WAS TESTED/ANALYZED. IN SUMMARY, THE PUMP, THE DEVICE DID NOT FAIL TO PERFORM ITS INTENDED FUNCTION AND IT DID NOT FAIL TO MEET ITS PERFORMANCE SPECIFICATIONS. BASED ON THE FACT THAT THE PUMP WAS NOT OUT OF SPECIFICATION; THE CUSTOMER USED THE PUMP FOR 2 DAYS, AND THE CUSTOMER WAS ALMOST EXCLUSIVELY BREAST FEEDING, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP 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: PUMP IN STYLE ADVANCED. PUMP MANUFACTURED ON: 07/27/2010 ON WORK ORDER # (B)(4). CIRCUIT BOARD DATA: MEDELA PART #9007040A; MANUFACTURER PART # W541; LOT CODE 0169. AC ADAPTER MEDELA PART #9200043. VACUUM LEVELS WERE MEASURED USING A KEYENCE GAUGE [NOTE 1 BELOW] - KEYENCE GAUGE - MODEL AP-31K; CALIBRATED ON (B)(4) 2010; NEXT CALIBRATION DUE DATE (B)(4) 2011; TESTED RANGE - 100 MMHG TO 300 MMHG; CALIBRATION ID (B)(4)], AND CYCLE COUNTS WERE DETERMINED BY COUNTING THE NUMBER OF CYCLES OVER A ONE MINUTE PERIOD AS MEASURED WITH A STOP WATCH [NOTE 2 - STOP WATCH - NULINE MODEL CMI0541; ID# (B)(4); CALIBRATED ON (B)(4) 2010; NEXT CALIBRATION DUE DATE (B)(4) 2011; TESTED RANGE - 30 SECONDS TO 600 SECONDS] AND THE FOLLOWING WERE THE RESULTS (NOTE: THE PUMP RAN FOR 30 SECONDS BEFORE ANY MEASUREMENTS WERE TAKEN): VACUUM AND CYCLE SPECIFICATIONS FOR THE PUMP ARE AS FOLLOWS: THE PUMP FUNCTIONED PROPERLY THROUGHOUT THE EXPERIMENT. A VISUAL INSPECTION OF THE PUMP REVEALED A CRACK IN THE SINGLE PUMPING PLUG. THE CRACK ONLY OPENED IF THE SINGLE PUMPING PLUG WAS PRESSED FIRMLY ONTO THE FACEPLATE PORT. THE CRACK DID NOT CAUSE THE PUMP TO PERFORM OUTSIDE OF ITS SPECIFIED RANGE. SUMMARY: CUSTOMER BEGAN USING A PURCHASED PUMP IN STYLE ADVANCED PUMP WHEN INFANT WAS ONE MONTH OLD; INFANT WAS EXCLUSIVELY BREASTFEEDING; PUMP SEEMED TO TURN ITSELF ON AND OFF; CUSTOMER PUMPED FOR 30 MINUTES AND STATED HER NIPPLES WERE SORE FROM PUMPING SO LONG; USED PUMP AGAIN TWO DAYS LATER; NIPPLES WERE STILL SORE; SAW HER OB MD AND WAS TREATED FOR MASTITIS FOR REDDENED BREAST ACCOMPANIED BY A FEVER; LACTATION CONSULTANT FOUND PUMP VACUUM TO BE LOW AND 24 MM BREAST SHIELDS TOO SMALL; FITTED FOR 27M M BREAST SHIELDS; CUSTOMER REQUESTED AND REC'D REPLACEMENT PUMP; HAS USED IT ONCE-NIPPLES ARE NO LONGER SORE, PUMP SEEMS TO BE FUNCTIONING OK BUT MOTHER STILL DOES NOT FEEL 'EMPTY' AFTER PUMPING. MASTITIS HAS RESOLVED; REVIEWED PUMPING TIPS WITH CUSTOMER AND SUGGESTED SHE SEEK LACTATION CONSULTANT'S ADVISE RE: RESIZING BREAST SHIELDS; INFANT REMAINS EXCLUSIVELY BREASTFEEDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE IS EXPERIENCING LOW SUCTION USING HER PUMP IN STYLE BREAST PUMP AND WHEN SHE HAD THE PUMP VACUUM TESTED BY A LACTATION CONSULTANT IT WAS FOUND TO BE LOW. THE CUSTOMER CLAIMS THAT THE LOW SUCTION CAUSED HER TO HAVE MASTITIS IN BOTH BREASTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1