BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3972857 · Received April 28, 2014

    Report

    Report Number
    1419937-2014-00390
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AND EVALUATED BY QE AND CONFIRMED A BREACH IN THE TRANSFORMER HOUSING. PRODUCT EVALUATION: EVALUATION SUMMARY: A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE VOLTAGE ACROSS THE DC PLUG WAS NOT MEASURED. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS AC BLADES MEASURED AS 54.5 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW. THIS ISSUE WITH A DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING., HANDLING AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STAKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING. THIS CORRECTIVE ACTION APPLIES TO TRANSFORMERS WITH A DATE CODE GREATER THAN OR EQUAL TO (B)(4). COMPLAINT DATA TRENDING WILL CONTINUE TO BE MONITORED BY MEDELA QUALITY MGMT FOR INVESTIGATION/CAPA CONSIDERATION. POSSIBLE RESOLUTIONS PROVIDED TO CUSTOMER: REPLACEMENT PRODUCT OR ONLINE ORDERING INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ORIGINALLY THAT HER PUMP IN STYLE DIAPHRAGM WAS BROKEN. UPON RECEIPT OF THE PRODUCT AND QE EVAL A BREACH IN THE TRANSFORMER HOUSING WAS OBSERVED WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253616 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA, INC. 57036/9207010 REV L - 1151

    Patients

    Seq Age Sex Outcome Treatment
    1