BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2091690 · Received April 29, 2011

    Report

    Report Number
    1419937-2011-00091
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN COMPLAINT FOLLOW UP ON (B)(6) 2011, THE CUSTOMER INDICATED THAT SHE BOUGHT THE PUMP IN 2008 FOR USE WITH HER FIRST BABY AND GOT THRUSH A FEW TIMES BUT THE BABY NEVER SHOWED SIGNS OF IT. SHE HAD A SECOND BABY IN (B)(6) OF 2011 AND USED THE SAME PUMP AND ACCESSORIES, THOUGH SHE CLEANED EVERYTHING. SHE GOT THRUSH AGAIN, THOUGH THE BABY IS NOT SHOWING SIGNS OF IT. A NURSE PRACTITIONER DIAGNOSED THE THRUSH AND SUGGESTED THAT YEAST IN THE PUMP CAUSED THE THRUSH. THE CUSTOMER WAS PRESCRIBED DIFLUCAN (X10 DAYS) AND AN ALL-PURPOSE NIPPLE OINTMENT; THE BABY WAS PRESCRIBED NYSTATIN "JUST IN CASE." IN CLINICAL FOLLOW UP ON (B)(6) 2011, THE CUSTOMER INDICATED THAT SHE BEGAN USING HER PREVIOUSLY USED PUMP TO EXPRESS MILK SINCE HER BABY WAS NOT SUFFICIENTLY DRAINING HER BREASTS. THE BABY WAS BORN VIA CESAREAN BIRTH AND THE CUSTOMER RECEIVED ANTIBIOTICS WHEN THE BABY WAS BORN. SHE DEVELOPED THRUSH AND HER NURSE PRACTITIONER ATTRIBUTED THE THRUSH TO THE PUMP. THE PUMP WAS RECEIVED FROM THE CUSTOMER FOR TESTING/ANALYSIS, WHICH INDICATED THAT THE PUMP WAS OPERATING WITH PRODUCT SPECS. A VISUAL EXAMINATION OF THE PUMP REVEALED THAT THE TUBING WAS DIRTY AND THE PUMP DID NOT APPEAR TO SHOW SIGNS OF AN OVERFLOW. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE THRUSH. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. EVAL SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: PUMP IN STYLE ADVANCED (9 VOLT). CIRCUIT BOARD DATA: MEDELA PART #9007026; SOFTWARE VERSION 5.0; MFR PART # B10477; LOT CODE 8058 (1). AC ADAPTER MEDELA PART #9207010; DATE CODE 14L. 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). VACUUM AND CYCLE SPECS FOR THE PUMP ARE AS FOLLOWS. THE VACUUM VALUES FOR THIS PUMP IN EXPRESSION MODE, MINIMUM SETTING, BOTH DOUBLE AND SINGLE PUMPING WERE NORMAL FOR PUMPS MADE WITH THE 9007026 CIRCUIT BOARD (APPROX 115 MMHG). THE THIRD PUMP WAS PRODUCED WITH THE CURRENT BOARD 9007040 WHICH MEETS OUR CURRENT VACUUM SPECS. THE TUBING SHOWED SIGNS OF A RESIDUE THAT APPEARED TO RESEMBLE DRIED MILK. THE PUMP DID NOT SHOW SIGNS OF AN OVERFLOW. CLINICAL ASSESSMENT: PER TELEPHONE CONVERSATION WITH CUSTOMER (B)(6) 2011: CUSTOMER STATED SHE BEGAN USING HER PREVIOUSLY UTILIZED PNSA WHEN INFANT WAS A FEW DAYS OLD; INFANT WAS NOT SUFFICIENTLY DRAINING BREASTS WHILE BREASTFEEDING AND NEEDED TO EXPRESS MILK; INFANT WAS BORN BY C/S AND CUSTOMER RECEIVED ANTIBIOTICS WHEN HER INFANT WAS BORN; DEVELOPED THRUSH; NURSE PRACTITIONER THOUGHT IT WAS FROM THE BREAST PUMP. SUMMARY: HIGHLY POSSIBLE THAT ANTIBIOTIC USE AFTER DELIVERY PRECIPITATED ONSET OF THRUSH; THRUSH IS CAUSED BY A FUNGAL OVERGROWTH OF CANDIDA ALBICANS AND IS FREQUENTLY SEEN AFTER ANTIBIOTIC TREATMENT, (P 567, LAWRENCE AND LAWRENCE, 6TH ED, 2005, BREASTFEEDING; A GUIDE FOR THE MEDICAL PROFESSION.) CONTINUE TO PUMP WITH REPLACEMENT PUMP; NIPPLES HAVE HEALED; BREASTFEEDING PROCEEDING WELL; NO FURTHER SYMPTOMS SINCE TREATMENT WITH DIFLUCAN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE GOT THRUSH WITH HER FIRST BABY AND PUT THE PUMP AWAY. SHE HAS NOW HAD A SECOND BABY AND SHE HAS THRUSH AGAIN. HER DOCTOR ADVISED HER THAT THE THRUSH IS COMING FROM THE PUMP SINCE THE PUMP HAD A MILK OVERFLOW AND CANNOT BE STERILIZED.

    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