| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COATED SX HARDSHELL RESERVOIR | BLOOD RESERVOIR | TERUMO CARDIOVASCULAR SYSTEMS CORP | DTN | 3CXSXRX | NA | TF11 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-14 | 0 | 1. O; 2. R |
Patient 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AND/OR MORE INFORMATION BECOMES AVAILABLE. (B)(4). EVALUATION CODE - CONCLUSIONS CODE: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.
Patient 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT CLOTS FORMED IN THE CARDIOTOMY RESERVOIR AND COULD BE SEEN OUTSIDE THE SOCK ON THE VENOUS SIDE. THE DEVICE WAS CHANGED OUT RESULTING IN APPROXIMATELY 1 LITER BLOOD LOSS AND PROCEDURE DELAY OF APPROXIMATELY 8 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND CURRENTLY THE PATIENT IS REPORTEDLY DOING WELL. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THAT THE PROCEDURE WAS OVER A 3-HOUR PUMP RUN. THE CLOTS WERE DETECTED ABOUT 2 HOURS AND 50 MINUTES INTO THE PROCEDURE, CLOSE TO TIME TO COME OFF PUMP AND REWARM. THE FIRST ACT ON PUMP WAS 700, AND THE LOWEST ACT WAS 472 - TAKEN 10 MINUTES BEFORE MAJOR CLOTTING OCCURRED. 5 MINUTES PRIOR TO THE DECISION TO CHANGE OUT THE RESERVOIR, 5,000 UNITS OF HEPARIN WERE GIVEN AND THE NEXT ACT WAS 666. PRIOR TO THE CHANGE OUT OF THE RESERVOIR, THE VENT WAS RUNNING AT 300 AND FULL OF BLOOD BEING RETURNED TO THE SUCKER. SUCKERS WERE RUNNING AT 600 AND FULL OF BLOOD BEING RETURNED TO THE RESERVOIR. A BLUE CAP "BLEW OFF" THE TOP OF THE RESERVOIR CAUSING BLOOD TO FLOW OUT OF THE TOP. THE USER FACILITY CONDUCTED ADDITIONAL PATIENT TESTING AND FOUND DEFICIENCIES IN THE PATIENT'S PROTEIN "C" AND PROTEIN "S" LEVELS BUT NO COLD AGGLUTINANTS WERE FOUND. REPORTEDLY, BLOOD PRODUCTS HAD BEEN ADMINISTERED TO THE PATIENT, AND IT IS UNDETERMINED WHETHER THE MENTIONED RESULTS WERE RELATED TO THE BLOOD PRODUCTS OR NATIVE TO THE PATIENT. BLOOD LOSS OF 1 LITER. DEVICE WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient 1
THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON OCTOBER 13, 2015. (B)(4). THE ACTUAL DEVICE WAS VISUALLY INSPECTED UPON RECEIPT. DARK SPOTS COULD BE SEEN IN THE CR FILTER CONFIRMING THAT CLOTTING HAD BEEN PRESENT IN THE FILTER DURING USE. NO OTHER ANOMALIES OR DAMAGE WERE FOUND ON THE DEVICE. FOLLOWING THE RESERVOIR CLOTTING TEST, THE ACTUAL DEVICE WAS BUILT INTO A CIRCUIT AND BOVINE BLOOD WAS CIRCULATED THROUGH THE CR FILTER AND RESERVOIR FOR ONE HOUR. NO PROBLEMS WERE FOUND WITH THE CIRCULATION DURING FLOW TESTING. AT THE END OF THE HOUR, THE ACTUAL DEVICE WAS DRAINED AND RINSED WITH DEIONIZED WATER. THE ACTUAL DEVICE WAS VISUALLY INSPECTED AND NO ADDITIONAL CLOTTING WAS NOTED IN COMPARISON TO HOW THE SAMPLE APPEARED PRIOR TO THIS TEST. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THERE WERE NO ANOMALIES. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THE PATIENT'S BLOOD CONDITIONS AND/OR PERFUSIONIST MANAGEMENT OF ACT WAS THE CAUSE OF THE ISSUE. (B)(4) - NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.