Description of Event or Problem · 1
PATIENT HAD DIFFICULT TRACH PLACEMENT IN ANOTHER INSTITUTION PRIOR TO ADMISSION. PATIENT WENT TO SURGERY FOR PLACEMENT OF A LONGER TRACH TUBE. TWO LANZ TUBES, THE BALLOONS BROKE UPON INSERTION OR SHORTLY THEREAFTER. PATIENT HAD TO REMAIN IN SURGERY FOR A LONGER PERIOD OF TIME. ANOTHER BRAND OF TRACH HAD TO BE USED INSTEAD OF THE LANZ. THE MANUFACTURER HAS BEEN OUT OF BUSINESS FOR SEVERAL YEARS. THE LANZ ATTEMPT WAS BECAUSE OF ANATOMICAL DIFFICULTIES WITH THE PATIENT'S TRACHEADEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: BALLOON. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.