Description of Event or Problem · 1
THIS 5 DAY OLD INFANT WAS RECEIVING IV ANTIBIOTICS FOR POSITIVE GROWTH OF BLOOD CULTURES. THE FIRST SITE INFILTRATED AND WAS DISCONTINUED. THE SECOND INSERTION SITE WAS THE LEFT ANTECUBITAL SPACE OBTAINED AT 11:00 P.M. AT 4:30 A.M., THE IV WAS INFUSING WITHOUT PROBLEMS VIA IV PUMP. BLOODTINGED FLUID WAS NOTED UNDERNEATH THE OPSITE DRESSING AT 0445. WHEN THE DRESSING WAS REMOVED, ONLY THE HUB OF THE CATHETER COULD BE FOUND. PRESSURE WAS IMMEDIATELY APPLIED ABOVE INSERTION SITE AND PHYSICIAN WAS CALLED. A CHEST X-RAY CONFIRMED THE POSITION OF THE CATHETER TO BE IN TEH PULMONARY ARTERY. ARRANGEMENTS WERE MADE WITH UVA FOR RETRIEVAL OF THE CATHETER. AT THE TIME OF TRANSFER BY AIR, THE INFANT SHOWED NO SYMPTOMS OF RESPIRATORY OR CARDIAC DISTRESS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, KNOWN SHORT TERM COMPLICATION OF PROCEDURE, HUB. CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, DEVICE TEMPORARILY REMOVED FROM SERVICE, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.