Description of Event or Problem · 1
SUDDEN CARDIAC ARREST OF THREE WEEK OLD MALE BORN AT 24 WEEKS GESTATION. STATUS POST HYALINE MEMBRANE DISEASE AND PATENT DUCTUS ARTERIOSUS. CURRENTLY WITH SEVERE BRONCHOPULMONARY DYSPLASIA THAT RESPONDED WELL TO DIURETICS, BRONCHODILATORS, AND TEROIDS. INFANT WITH PERUITANEUS CENTRAL LINE THAT APPEARED RADIOGRAPHICALLY IN RIGHT ATRIUM. SUDDEN ARREST WITHOUT ANY RESPONSE TO RESUSCITATION. MICROSCOPIC AUTOPSY RESULTS PENDING, BUT PROVISIONAL DIAGNOSIS INDICATED CARDIAC TOMPONADE CAUSED BY RUPTURE OF RIGHT ATRIUM BY PERCUTANEOUS CENTRAL VENOUS CATHETER WITH LEAK OF HYPERALIMENTATION FLUID INTO PERICARDIUM. 5CC OF SIMILAR FLUID IN RIGHT PLEURAL CAVITYDEVICE 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.