BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2212570 · Received August 11, 2011

    Report

    Report Number
    1419937-2011-00165
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT THE BREAST PUMP HAS "REALLY STRONG, STRONG SUCTION," WHICH CAUSES PAIN. SHE THOUGHT THAT MAYBE SHE WAS JUST SENSITIVE, SO SHE RENTED A HOSPITAL-GRADE PUMP. HOWEVER, SHE DOES NOT EXPERIENCE PAIN WITH THE HOSPITAL-GRADE PUMP. SHE INDICATED THAT HER BREASTS WERE TURNING PURPLE. SHE CONSULTED BOTH A LACTATION CONSULTANT AND A DOCTOR FOR MASTITIS AND SEVERAL CLOGGED DUCTS. SHE WAS TREATED WITH ANTIBIOTICS AND A TOPICAL CREAM. SHE WAS EXCLUSIVELY PUMPING WHEN SHE WAS DIAGNOSED WITH THE MASTITIS. SHE IS CURRENTLY USING THE REPLACEMENT PUMP WITHOUT ISSUE AND IS PUMPING WITHOUT PAIN. "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." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. THE BREAST PUMP WAS RETURNED BY THE CUSTOMER FOR TESTING/ANALYSIS. IN SUMMARY, THE PUMP FAILED TO MEET ALL OF ITS PERFORMANCE SPECIFICATIONS; THE MINIMUM AND MAXIMUM VACUUM LEVELS IN BOTH STIMULATION AND EXPRESSION PHASES WHILE SINGLE PUMPING WERE ABOVE THE SPECIFICATIONS. DESPITE THE FACT THAT THE PUMP WAS OUT OF SPECIFICATION, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. EVALUATION SUMMARY: THE PUMP WAS VISUALLY EXAMINED AND THE FOLLOWING WERE NOTED: PUMP TYPE: PUMP IN STYLE ADVANCED. PUMP MANUFACTURED ON: 09/09/2008. CIRCUIT BOARD DATA: MEDELA PART #9007026A; SOFTWARE VERSION 5.0; MANUFACTURER PART # BIO477A; LOT CODE 8150(2). AC ADAPTER MEDELA PART #9207010. VACUUM LEVELS AND CYCLE RATES WERE MEASURED. THE VACUUM VALUES FOR THIS PUMP IN EXPRESSION PHASE, MINIMUM SETTING, BOTH DOUBLE AND SINGLE PUMPING SHOULD HAVE BEEN APPROXIMATELY 115 MMHG FOR PUMPS MADE WITH THE 9007026 CIRCUIT BOARD. THE TRANSFORMER VOLTAGE WAS CHECKED AND THE TRANSFORMER WAS FOUND TO BE IN PROPER CONDITION. THE PUMP WAS OUT OF SPECIFICATION (VACUUM LEVELS TOO HIGH) FOR THE FOLLOWING SETTINGS: STIMULATION PHASE, MINIMUM VACUUM, SINGLE PUMPING. STIMULATION PHASE, MAXIMUM VACUUM, SINGLE PUMPING. EXPRESSION PHASE, MINIMUM VACUUM, SINGLE PUMPING. EXPRESSION PHASE, MAXIMUM VACUUM, SINGLE PUMPING. NOTE 1 - VACUUM AND CYCLE RATES WERE MEASURED USING MEDELA PART NUMBER 700.2020 - VACUUM/CYCLE FIXTURE (ID# 3058); CALIBRATED DAILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE HAS HAD HER BREAST PUMP FOR ABOUT ONE YEAR AND HAS NEVER REALLY BEEN ABLE TO USE IT MUCH DUE TO THE PAIN SHE FEELS WHEN PUMPING. SHE USES THE PUMP ON THE LOWEST SETTING AND STILL FEELS PAIN. WHEN SHE USES A HOSPITAL-GRADE PUMP, SHE DOES NOT FEEL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other