BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 7450121 · Received April 23, 2018

    Report

    Report Number
    1419937-2018-00109
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 22, 2018
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING PARTS, CLEANING AND REASSEMBLING. FOLLOWING TROUBLESHOOTING, THE CUSTOMER INDICATED THAT THE SUCTION WAS RESTORED AND MENTIONED THAT SHE SOMETIMES HAS TO PULL OUT THE CENTER MEMBRANE TO GET IT TO LAY FLAT. THE CUSTOMER CALLED BACK ON (B)(6) 2018 AND ALLEGED TO MEDELA LLC THAT SHE HAD CLOGGED DUCTS OVER THE PUMP AND SHE WAS ON MEDICATION FOR THRUSH. THE CUSTOMER INDICATED THAT SHE HAD EXTRA PARTS AND TUBING AND TRIED THOSE, BUT IT DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF THE ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THE DEVICE WAS RETURNED WITH THE CUSTOMER'S PARTS AND ACCESSORIES AND WAS EVALUATED ON (B)(6) 2018. THE PUMP FAILED SUCTION AND CYCLE SPECIFICATIONS AND A LEAK ON THE CONNECTOR SEALING SURFACE WAS IDENTIFIED, ALONG WITH A DAMAGED BARRIER AND RESIDUE ON THE CONNECTOR. THE DEVICE WAS THEN EVALUATED WITH A MEDELA LAB KIT ON (B)(6) 2018 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. REFER TO ATTACHED EVALUATION. THE REPORT OF LOW SUCTION WAS CONFIRMED. THE ROOT CAUSE OF THE LOW SUCTION ISSUE CAN BE ATTRIBUTED TO A MOLDING DEFICIENCY ON THE CONNECTORS SEALING SURFACE. CURRENTLY THERE IS AN OPEN INVESTIGATION (CAPA-(B)(4)), WHICH IDENTIFIED MOLDING ENHANCEMENTS TO CORRECT THIS DEFICIENCY WHICH WERE PUT IN PLACE IN (B)(6) OF 2017. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S THRUSH. REPORTED ISSUES OF THRUSH WERE INVESTIGATED UNDER (B)(4) AND THE ROOT CAUSES WERE IDENTIFIED AS: LACK OF EDUCATION/TRAINING TO MOTHERS ON BREAST FEEDING AND BREAST MILK PUMPING; INSUFFICIENT GUIDANCE ON BREAST SHIELD SIZING TO PREVENT NIPPLE TRAUMA; INSUFFICIENT PERSONAL HYGIENE PRACTICES PRIOR TO BREAST MILK PUMPING OR BREAST FEEDING; AND NO ACCESS TO OR NOT FOLLOWING THE MANUFACTURES' INSTRUCTIONS FOR THE CLEANING AND SANITATION OF THE BREAST MILK PUMPING COMPONENTS. NO CORRECTIVE ACTIONS RESULTED AS IT WAS DETERMINED THAT DETAILED INSTRUCTIONS ARE AVAILABLE AND ADEQUATE IN BOTH PRINTED AND ON-LINE FORMATS FOR CLEANING BREAST MILK PUMPING EQUIPMENT, PERSONAL HYGIENE, PROPER BREAST SHIELD SIZING TO PREVENT NIPPLE SORENESS/TRAUMA, WHICH CAN LEAD TO SKIN BREACHES, ALLOWING FOR THE POTENTIAL INTRODUCTION OF YEAST. [(B)(4).PDF].

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING AN ISSUE WITH INTERMITTENT SUCTION WHEN USING HER FREESTYLE BREAST PUMP. THE CUSTOMER INDICATED THAT SHE ATTEMPTED TROUBLESHOOTING HERSELF PRIOR TO CALLING AND THAT AT TIMES THE PUMP WOULD HAVE GOOD SUCTION AND AT OTHER TIMES HAVE NO SUCTION AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294429 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060 432658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other