Description of Event or Problem · 1
FOUR WEEK OLD FEMALE INFANT BORN AT 25 WEEKS GESTATION WITH SEVERE BROCHOPULMONARY DYSPLASIA. STATUS POST DECADRON FOR TREATMETN OF BRONCHOPULMONARY DYSPLASIA. EXTUBATED IN LATE FEBRUARY. HYPERALIMENTATION ADMINISTERED THROUGH PERCUTANEOUS CENTRAL LINE. ON 3/2/92 PATIENT HAD INCREASED RESPIRATORY DISTRASS. REINTUBATED. DISTRESS WORSENED AND PLEURAL EFFUSION NOTED ON CHEST X-RAY 3/3/92. APPROXIMATELY, 12 CC MILKY WHITE FLUID REMOVED FROM CHEST AND APPROXIMATELY 9CC FROM RIGHT CHEST WITH NEEDLE ASPIRATION. BILATERAL CHEST TUBES PLACED. ARGYLE CATHETER, 12 FR, SHERWOOD MEDICAL) ONE HOUR LATTER, DECREASED BLOOD PRESSURE, AND BLEEDING NOTED PER RIGHT SIDED CHEST TUBE. DESPITE MASSIVE VOLUME RESUSCITATION AND OPEN THORACOTOMY, PATIENT EXPIREDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.