BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCEAN WET SUCTION WATER SEAL DRAIN

    MDR report key: 2170620 · Received July 18, 2011

    Report

    Report Number
    MW5021372
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ATRIUM MED CORP
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) GESTATION INFANT WHO WAS BORN BY AUGMENTED VAGINAL DELIVERY PRESENTED WITH MILD RESPIRATORY DISTRESS WITH RETRACTIONS AND EXPIRATORY GRUNTING. APGAR SCORES WERE 8 AND 9. INFANT RECEIVED MASK CPAP AND BMV IN THE DELIVERY ROOM AND WAS TRANSFERRED TO INTENSIVE CARE NURSERY W/O INCIDENT ON NCPAP. ON DAY OF (B)(6) INFANT DEVELOPED A RIGHT SIDED TENSION PNEUMOTHORAX THAT WAS NEEDLED X2 AND THEN REQUIRED A CHEST TUBE PLACEMENT. A PLEUROVAC WAS SET UP IN "USUAL FASHION" (CONNECT TO WALL SUCTION). THE CHEST TUBE WAS CONNECTED TO PLEUROVAC AND NO "BUBBLING" WAS NOTED AT THAT TIME. INFANT'S CONDITION DETERIORATED WITH INCREASING CO2 LEVELS AND LABORED "BREATHING." INFANT WAS THEN RE-INTUBATED BY PHYSICIAN. A SECOND (REPLACEMENT) PLEUROVAC WAS SET UP IN "USUAL FASHION", (CONNECTED TO WALL SUCTION) AND CHEST TUBE. INFANT THEN EXPERIENCED RAPID IMPROVEMENT WITH DECREASING CO2 LEVELS AND LABORED BREATHING. ON (B)(6) 2011, INFANT EXTUBATED W/O COMPLICATIONS AND REMAINS UNDER INTENSIVE CARE SVS FOR OTHER "PREMATURITY" RELATED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCEAN WET SUCTION WATER SEAL DRAIN PLEUROVAC KDQ ATRIUM MED CORP 2012 SERIES 10496405 OR 10543622

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other