Description of Event or Problem · 1
PT HAS TRACHEOSTOMY AND #5.5 BIVONA PEDIATRIC CUFFED TRACHS ARE PRESCRIBED. CLIENT HAS RECEIVED A TOTAL OF FOUR DEFECTIVE TRACHS FROM DME PROVIDER, PEDIATRIC SPECIALISTS WITH THE LOT# 1565140. TRACH CUFF DOES NOT PROPERLY INFLATE. ONLY ONE SIDE OF CUFF WILL INFLATE. PT'S MOTHER PROVIDED AN UNSCHEDULED TRACH CHANGE IN THE HOME ON (B) (6) 2010, DUE TO PT HAD AN INCREASED WORK OF BREATHING AND INCREASED CONGESTION. UPON REMOVAL OF EXISTING TRACH, IT WAS FOUND THAT CUFF WAS NOT INFLATED ON ONE SIDE. MOTHER REPLACED TRACH WITH A SANITIZED 5.5 BIVONA PEDIATRIC TRACH THAT WAS AVAILABLE IN THE HOME FOR RE-USE WITH A CUFF THAT PROPERLY INFLATED. CLIENT'S RESPIRATORY STATUS WAS PROMPTLY STABILIZED AFTER TRACH CHANGE. DURABLE MEDICAL EQUIPMENT PROVIDER, PEDIATRIC SPECIALISTS WAS NOTIFIED OF INITIAL DEFECT. SINCE THAT DATE PT HAS BEEN DELIVERED -4- #5.5 BIVONA PEDIATRIC TRACHS THAT HAD THE SAME DEFECT WITH THE CUFF. THE DEFECTIVE TRACHS WERE CHECKED FOR PROPER CUFF INFLATION AND WERE NOT USED DUE TO CONTINUED DEFECT. PEDIATRIC SPECIALISTS WAS PROMPTLY NOTIFIED OF EACH DEFECTIVE TRACH RECEIVED. ORIGINAL DEFECTIVE TRACH WAS SENT BACK TO PEDIATRIC SPECIALISTS WHO CONFIRMED DEFECT AS WELL. DME PROVIDER REPORTED THAT FDA REPORTING WOULD ALSO BE SUBMITTED. DATES OF USE: 5 DAYS BEST ESTIMATE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: WERDNIG-HOFFMAN SYNDROME -SPINAL MUSCULAR ATROPHY-, RESPIRATORY FAILURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.