BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7141692 · Received December 22, 2017

    Report

    Report Number
    1419937-2017-00358
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 22, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451570815
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED WITH THE CUSTOMER'S PARTS AND ACCESSORIES AND IT MET ALL VACUUM AND CYCLE SPECIFICATIONS, EVEN THOUGH IT WAS NOTED THAT THE TUBING WAS DIRTY, AND IT PASSED POWER TESTING. REFER TO ATTACHED EVALUATION.

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING THE POWER SUPPLY FOR DAMAGE AND POWERING THE PUMP ON. DURING TROUBLESHOOTING, THE PUMP POWERED ON WITH THE POWER SUPPLY, BUT THEN SHUT OFF ON ITS OWN. THE CUSTOMER INDICATED THAT THE POWER SUPPLY WAS SECURELY PLUGGED INTO THE PUMP. A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2017, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS FROM THE PUMP NOT EMPTYING HER, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS. SHE INDICATED THAT SHE HAD DEVELOPED BLISTERS ON THE END OF HER NIPPLES. THE CUSTOMER STATED THAT SHE HAS RECEIVED HER NEW PUMP AND IT WAS WORKING WITHOUT ISSUE. 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) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WOULD STOP PUMPING AND WOULDN'T POWER BACK ON FOR A FEW MINUTES. THE CUSTOMER ALSO ALLEGED THAT SHE WAS HAVING TO TURN THE PUMP VACUUM UP HIGHER THAN USUAL AND IT WAS HURTING HER NIPPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921861 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 430841 00020451570815

    Patients

    Seq Age Sex Outcome Treatment
    1 Other