BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP, BREAST, POWERED

    MDR report key: 2029494 · Received March 22, 2011

    Report

    Report Number
    1419937-2011-00016
    Event Type
    Death
    Date Received
    March 22, 2011
    Date of Event
    May 6, 2009
    Report Date
    February 23, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BREAST PUMP DEVICE THAT THE MOTHER USED TO EXPRESS MILK INTO THE BOTTLES IS UNK. THE BREAST PUMP KITS CLAIMED TO BE USED WERE EITHER: (B)(4) SYMPHONY STERILE KIT; OR (B)(4) SYMPHONY/LACTINA DOUBLE STERILE KIT; OR (B)(4) LACTINA DOUBLE PUMP STERILE KIT; OR (B)(4) UNIVERSAL STERILE PUMP KIT. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT AT THIS TIME. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE REC'D, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(6). A BABY BOY WAS BORN ON (B)(6) 2009, AT A HOSPITAL IN (B)(6). DUE TO HIS PREMATURITY, THE BABY WAS ADMITTED TO THE SPECIAL CARE NURSERY. ON (B)(6) 2009, THE BABY'S MOTHER BEGAN USING A BREAST PUMP, ALONG WITH A BREAST PUMP KIT, TO EXPRESS HER BREAST MILK INTO BOTTLES. THE BREAST MILK WAS FED TO THE BABY, VIA BOTH BOTTLE AND NASOGASTRIC TUBE; SOME WAS FROZEN. ON (B)(6) 2009, THE BABY WAS DIAGNOSED WITH SERRATIA SEPSIS AND MENINGITIS. THE BABY EXPIRED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP, BREAST, POWERED UNKNOWN HGX MEDELA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Death