BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 12957062 · Received December 7, 2021

    Report

    Report Number
    1419937-2021-00110
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 22, 2021
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET AND IT WAS DETERMINED THAT THE CUSTOMER WAS NOT USING THE CORRECT CONNECTORS. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND WAS EVALUATED ON 12/29/2021. THE DEVICE DID NOT POWER ON WITH THE CUSTOMER'S BATTERY PACK OR POWER SUPPLY. IT WAS TESTED WITH THE MEDELA LAB BATTERY PACK AND POWER SUPPLY AND ALSO DID NOT POWER ON. HUMAN MILK RESIDUE WAS FOUND ON THE HOUSING, THE AGGREGATE (INTERNAL MOTOR & PUMP ASSEMBLY), CHASSIS, DC JACK, MANIFOLD, MOTOR, WIRE HARNESS AND SOLENOID. A DIRTY FABRIC LOOP WAS IDENTIFIED. THE ECCENTRIC MOTOR SHAFT IS OUT OF SPEC. THE CUSTOMER'S REPORT OF MILK BACKUP WAS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD A MILK BACKUP WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP AND NOW SHE HAS NO SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE HAS MASTITIS AND WAS ON AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855697 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 0000030779 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other