BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA DELUXE SINGLE PACK

    MDR report key: 8354786 · Received February 20, 2019

    Report

    Report Number
    1419937-2019-00024
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    January 24, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451582009
    PMA / PMN Number
    K161725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITH THE POWER SUPPLY AND WAS EVALUATED ON(B)(6)2019. THE DEVICE FAILED POWER TESTING, EVEN AFTER THE PC BOARD WAS EXCHANGED WITH A LAB PC BOARD. THE PUMP WAS THEN TESTED USING THE CUSTOMER PC BOARD AND A LAB BATTERY AND IT PASSED THE POWER TEST, THUS ISOLATING THE ISSUE TO THE CUSTOMER'S BATTERY. ADDITIONALLY, RESIDUE ON THE PUMP AND PUMP FUNCTIONAL UNIT WERE NOTED. REFER TO ATTACHED EVALUATION. PER PAGE 5 OF THE INSTRUCTIONS FOR USE, THE OPERATING LIFE OF THE SONATA BREAST PUMP IS DEFINED TO BE APPROXIMATELY THREE 15-MINUTE SESSIONS PER DAY, FOR ONE YEAR, WHICH EQUATES TO A TOTAL UTILIZATION TIME OF APPROXIMATELY 274 HOURS. DURING THE PRODUCT EVALUATION, THE PUMP OPERATING HOURS WERE IDENTIFIED AS 460.6 HOURS, WHICH EXCEEDS THE 274 HOUR OPERATING LIFE OF THE PUMP. THOUGH THE PRODUCT EVALUATION CONFIRMED THE CUSTOMER'S REPORT OF A BATTERY CHARGING ISSUE, AFTER REVIEWING THE PRODUCT INSTRUCTIONS FOR USE AND DETAILS FROM THE PUMP DIAGNOSTICS, IT APPEARS THAT THE PUMP HAD REACHED THE END OF ITS OPERATING LIFE.

    Additional Manufacturer Narrative · 1

    AN EMAIL RESPONSE WAS SENT TO THE CUSTOMER, REQUESTING THAT SHE CONTACT CUSTOMER SERVICE VIA PHONE SO THAT HER ISSUE COULD BE APPROPRIATELY BE ADDRESSED, WHICH SHE DID ON (B)(6) 2019. ON THAT DATE, SHE ALLEGED THAT SHE WAS PRESCRIBED ANTIBIOTICS BY HER DOCTOR. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2019, THE CUSTOMER CONFIRMED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2019. SHE INDICATED THAT SHE HAD RECEIVED HER REPLACEMENT PUMP AND THE MASTITIS WAS RESOLVED. BASED ON THE RESULTS OF (B)(4), IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. THE ESTIMATED INCIDENCE OF MASTITIS IN LACTATING WOMEN, WHETHER USING A BREAST PUMP OR NOT, ACCORDING TO PUBLISHED CLINICAL LITERATURE CAN BE AS HIGH AS 33%. IN FACT, CLINICAL GUIDELINES SUGGEST THE USE OF A BREAST PUMP TO FACILITATE WITHDRAWAL OF BREAST MILK DURING BOUTS OF MASTITIS. THE COMPLAINT RATE OF MASTITIS ACROSS ALL REPORTED FAILURES, ACROSS ALL MEDELA BREAST PUMPS, IS 0.008% FOR THE PERIOD OF JANUARY 2013 TO AUGUST 2017. 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 OR MASTITIS." RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE CUSTOMER EMAILED MEDELA LLC ALLEGING THAT THE BATTERY ON HER SONATA BREAST PUMP DISCHARGES IMMEDIATELY AFTER UNPLUGGING FROM MAINS POWER, EVEN WHEN IT SHOWS A FULL CHARGE. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149704 SONATA DELUXE SINGLE PACK PUMP, BREAST, POWERED HGX MEDELA LLC 58200 436580 00020451582009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other