PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE XTRA DISPOSABLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT SAMPLES TAKEN FROM BLOOD PROCESSED USING AN XTRA AUTOTRANSFUSION DEVICE SHOWED HEMOLYSIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION BUT THERE WAS NO INJURY. A REPORT AGAINST THE EQUIPMENT WAS FILED UNDER MEDWATCH NUMBER 9611109-2015-00346. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
D
Patient 1
SORIN GROUP RECEIVED A REPORT THAT SAMPLES TAKEN FROM BLOOD PROCESSED USING AN XTRA AUTOTRANSFUSION DEVICE SHOWED HEMOLYSIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION BUT THERE WAS NO INJURY.
N
Patient 1
SORIN GROUP (B)(4) MANUFACTURES THE XTRA DISPOSABLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT SAMPLES TAKEN FROM BLOOD PROCESSED USING AN XTRA AUTOTRANSFUSION DEVICE SHOWED HEMOLYSIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION BUT THERE WAS NO INJURY. A REPORT AGAINST THE EQUIPMENT WAS FILED UNDER MEDWATCH NUMBER 9611109-2015-00346. THE DEVICE WAS NOT RETURNED TO SORIN GROUP FOR INVESTIGATION, BUT AN INVESTIGATION WAS PERFORMED BY THE CUSTOMER. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER HAS REVEALED THAT THE REPORTED ISSUE WAS UNRELATED TO THE XTRA AUTOTRANSFUSION DEVICE AND THE DISPOSABLE. A PATHOLOGIST ANALYZED THE CELL SAVER BLOOD AND WAS ABLE TO RULE OUT ANY ISSUES WITH THE BLOOD. AFTER A FULL INVESTIGATION, THE FACILITY CONCLUDED THAT THE ISSUE EXPERIENCED BY THE PATIENT WAS NOT RELATED TO CELL SALVAGE. THE PATIENT WAS ON ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS AT THE TIME OF THE EVENT, WHICH ARE WIDELY USED AS TREATMENT FOR HYPERTENSION. HYPOTENSION IS A POTENTIAL SIDE EFFECT OF THE USE OF THESE DRUGS. A REVIEW OF THE DHR WAS UNABLE TO IDENTIFY ANY CONCESSIONS, DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. NO TRENDS WAS IDENTIFIED FOR THIS TYPE OF ISSUE; THIS IS THE FIRST REPORT OF POTENTIAL CORRELATION BETWEEN HYPOTENSION AND THE USE OF THE XTRA MACHINE AND DISPOSABLES. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS ISSUE. INVESTIGATION PERFORMED BY CUSTOMER.
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL