BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNSA STARTER BP EN ES USA

    MDR report key: 9768800 · Received February 28, 2020

    Report

    Report Number
    1419937-2020-00016
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    December 8, 2019
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON (B)(6)2020 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. THE DEVICE PASSED SUCTION AND CYCLE SPECIFICATIONS. ADDITIONAL TESTING WAS PERFORMED AND THE DEVICE MET SPECIFICATIONS AFTER THREE ADDITIONAL TEST CYCLES. REFER TO ATTACHED PRODUCT EVALUATION. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT TROUBLESHOOTING TIPS VIA EMAIL. THE CUSTOMER PHONED IN ON (B)(6)2020 AND 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) 2020, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2019 AND AGAIN ON (B)(6) 2020 AND WAS PRESCRIBED ANTIBIOTICS. SHE INDICATED THAT THE MASTITIS WAS RESOLVED SINCE USING A MEDICAL GRADE PUMP WHICH SHE WAS RENTING. BASED ON THE RESULTS OF 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 (B)(6) 2013 TO (B)(6) 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 ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP LOST SUCTION AND THAT A LACTATION CONSULTANT TESTED THE PUMP AT 125 MMHG AT THE HIGHEST SETTING, RATHER THAN THE EXPECTED 250 MMHG. SHE WAS SENT A REPLACEMENT PUMP. ON (B)(6)2020, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL AGAINST THE REPLACEMENT PUMP THAT SHE HAD TWO (2) CASES OF MASTITIS IN THE LAST 45 DAYS AND HER DOCTOR ADVISED HER TO CHECK HER PUMP SUCTION, WHICH WAS AT 60 MMHG WHEN TURNED TO THE HIGHEST SETTING. SHE FURTHER ALLEGED THAT SHE DID ALL OF THE RECOMMENDED TROUBLESHOOTING, WHICH DID NOT RESOLVE THE SUCTION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232521 PNSA STARTER BP EN ES USA PUMP, BREAST, POWERED HGX MEDELA LLC 101035077 456726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other