BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA PUMP W/FLEX SINGLE 1CT EN FR ES

    MDR report key: 16477004 · Received March 3, 2023

    Report

    Report Number
    1419937-2023-00011
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 3, 2023
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451367507
    PMA / PMN Number
    K161725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND PARTS, THE RETURN OF HER ORIGINAL PUMP AND PARTS WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2023, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2023 AND WAS PRESCRIBED AN DICLOXACILLIN. SHE INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND HER MASTITIS WAS RESOLVED. THE DEVICE WAS RETURNED WITH THE CUSTOMER'S TRANSFORMER AND WAS EVALUATED ON (B)(6)2023. THE DEVICE WAS TESTED WITH A LAB TRANSFORMER AND THE CUSTOMER'S TRANSFORMER AND THE ISSUE OF NO POWER WAS REPRODUCED. IN THE EVALUATION IT WAS DISCOVERED THAT THE POWER BOARD HARNESS WAS LOOSE/DETACHED FROM THE MAIN BOARD. ONCE THE POWER BOARD HARNESS WAS RE ATTACHED THE PUMP POWERED ON SUCCESSFULLY. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (REFERENCE NUMBER CA11-001),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 OF MASTITIS. RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. HOWEVER IN THIS CASE, THE MOTHER¿S MASTITIS REQUIRED PROMPT MEDICAL ATTENTION FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 0

    ON 2/13/23, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER SONATA BREAST PUMP IT WOULD NOT POWER ON, THE DISPLAY WOULD NOT SHOW THAT THE POWER CORD WAS PLUGGED IN. THE CUSTOMER STATED THE PUMP WS DROPPPED BEFORE THE ISSUE BEGAN. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS TO TREAT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023345 SONATA PUMP W/FLEX SINGLE 1CT EN FR ES PUMP, BREAST, POWERED HGX MEDELA LLC 101037319 0000043916 00020451367507

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other