Description of Event or Problem · 1
ON 3/2/93, THE PATIENT WAS SCHEDULED FOR SURGERY. SHORTLY AFTER INDUCTION, THE [ATIENT DEVELOPED BRONCOSPASMS AND THEN CONTINUED INTO A CARDIOVASCULAR AARREST PRESENTING PROFOUND HYPOTENSION. RESUSCITATION MEASURES WERE INITIATED AND THE PATIENT MOVED TO AN INTENSIVE CARE UNIT. THE PATIENT SUBSEQUENTLY EXPIRED ON 3/7/93. PRIOR TO THE PATIENT'S EXPIRATION A SERUM SAMPLE WAS OBTAINED AND SENT FOR LATEX ALLERGY TESTING. THE TEST RESULTS INDICATED A POSITIVE REACTION. AT THAT TIME AN MDR REPORT WAS SUBMITTED TO THE USP LISTING THE TWO MANUFACTURERSDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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 DISCARDED, USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.