BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN)

    MDR report key: 14345621 · Received May 10, 2022

    Report

    Report Number
    1419937-2022-00044
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451412658
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER CONFIRMING NO MILK BACKUP HAD OCCURRED; AND VERIFYING CORRECT KIT COMPONENTS WERE BEING USED AND WASHED ACCORDING TO OUR INSTRUCTIONS FOR USE. THE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 5/4/2022, THE CUSTOMER STATED THAT HER MASTITIS STARTED AROUND (B)(6) 2022 AND SHE WAS PRESCRIBED KEFLEX BY HER DOCTOR. THE CUSTOMER ALSO INDICATED THAT SHE HAS COMPLETED HER ANTIBIOTIC AND THE REPLACEMENT PUMP IS WORKING WELL. THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED ON 5/09/2022, WITH A MEDELA LAB KIT AND DID NOT PASS SUCTION AND CYCLE SPECIFICATIONS. THE EVALUATION FOUND HUMAN MILK RESIDUE IN THE PUMP AGGREGATE (MOTOR AND PUMP ASSEMBLY). THE CUSTOMER'S REPORT OF LOW SUCTION WAS CONFIRMED. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (REFERENCE NUMBER (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 (B)(4) 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 (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT IT WAS TAKING HER A LONG TIME EMPTY HERSELF DUE TO THE SUCTION ON HER PUMP IN STYLE MAX FLOW AND IS ENGORGED. ADDITIONALLY, SHE ALLEGED THAT SHE WENT TO (B)(6) OVER THE WEEKEND DUE TO MASTITIS AND WAS PLACED ON AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653054 PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041265 0000039999 00020451412658

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other