BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1140263 · Received August 29, 2008

    Report

    Report Number
    6000001-2008-00499
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER QUALITY MANAGEMENT FOR EVAL BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON 8/26/2008, BAXTER RECEIVED A REPORT OF A FREE FLOW OF PITOCIN TO A FEMALE PT ON A FLOGARD INFUSION PUMP, WHICH OCCURRED ON TEN DAYS EARLIER. ON THE SAME DAY(EVENT DAY) AT 0755, PITOCIN WAS STARTED ON THE FLOGARD PUMP. AT 0801, THE PUMP WAS TURNED OFF. THE TUBING REMAINED IN THE PUMP. AT 0808, THE NURSE NOTED THAT PITOCIN WAS RUNNING AT BOLUS RATE DESPITE PUMP IN THE OFF STATUS. THE MOM DELIVERED AT 0809, A MALE WHO HAD LOW APGARS AND SEIZURE ACTIVITY. THE BABY WAS BORN FLOPPY AND CYANOTIC. HE WAS NOT BREATHING. HIS HEART RATE WAS GREATER THAN 100. THE BABY WAS VENTILATED BY BAG AND MASK. AFTER 2 MINUTES, THE BABY WAS NOT BREATHING ON HIS OWN. HE WAS STIMULATED, GIVEN OXYGEN AND VIGOROUS CHEST PHYSICAL THERAPY, AND BULB SUCTIONING. THE BABY HAD A WEAK CRY. AT 5 MINUTES THE APGAR INCREASED TO 7 AND AT 10 MINUTES IT WAS 8. THE BABY HAD ELECTROLYTES AND LIVER FUNCTION LEVELS DONE ON EVENT DAY. THE MOM HAD ELECTROLYTES, BLOOD CULTURES, AND CHEST X-RAY PERFORMED ON THE SAME DAY. THE MOM HAD NO NOTED PROBLEMS. THE MOM AND BABY WERE DISCHARGED FROM THE HOSPITAL ON TWO DAYS LATER AND DOING WELL. THE PUMP IS AVAILABLE FOR EVAL. THE TUBING PRODUCT CODES AND LOT NUMBERS ARE UNK AND WERE DISCARDED. ON 8/28/2008, BAXTER RECEIVED THE FOLLOWING ADDITIONAL CLINICAL INFO: THE MOTHER WAS ON A FETAL AND CONTRACTION MONITOR BEFORE AND DURING THE DELIVERY. THE MOTHER'S LABOR BEGAN AT 0415 AND CONTRACTIONS WERE EVERY 3-5 MINUTES. AT 0530 CONTRACTIONS WERE EVERY 2-3 MINUTES. AT 0630 CONTRACTIONS WERE EVERY 3-4 MINUTES. AT 0715, CONTRACTIONS WERE EVERY 4-4.5 MINUTES. AT 0730 THE CONTRACTIONS WERE EVERY 5-5.5 MINUTES APART. AT 0759, THE FETAL HEART RATE HAD DECELERATED FROM THE 100S TO 70S FOR ONE MINUTE. THE MOTHER WAS TURNED ON HER SIDE. AT 0800, THE FREQUENCY OF CONTRACTIONS WERE EVERY 2 MINUTES WITH DURATION OF 60 SECONDS. AT 0802, THE FETAL HEART RATE WAS 130-140 FOR BRIEF RECOVERY, BUT THEN THE FETAL HEART RATE DROPPED TO 58. AT 0804, THERE WAS A PROLONGED DECELERATION WITH VERTEX. AT 0809, THE MALE BABY WAS BORN. THIS COMPLAINT WAS OPENED FOR THE INCIDENT INVOLVING THE BABY AND THERE'S ANOTHER MEDWATCH FILED FOR THE MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN BAXTER HEALTHCARE PTE. LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening| R