DEGLYCE/CELL WASH SET, 275 ML

Additional Manufacturer Narrative

ONE BAG SAMPLE WAS RETURNED TO HAEMONETICS FOR EVALUATION. THE EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE EVALUATION RESULTS ARE AVAILABLE.

Description of Event or Problem

HAEMONETICS RECEIVED A REPORT FROM A CUSTOMER ON (B)(6) 2016 STATING THAT A PLANNED INTRA-UTERINE TRANSFUSION HAD TO BE CANCELED DUE TO TWO RED CELL BAGS LEAKING AFTER CENTRIFUGATION. THESE RED CELL BAGS HAD BEEN DE-GLYCEROLIZED UTILIZING THE HAEMONETICS® ACP®215 DEVICE . THE CUSTOMER THEN TOOK THE BAG AND CENTRIFUGED IT IN ORDER TO CONCENTRATE THE RBCS TO A HEMATOCRIT OF 0,70-0,85. THE CENTRIFUGATION OF THE BAGS IS NOT A STEP IN THE DE-GLYCEROLIZATION PROCESS THAT HAEMONETICS OUTLINES IN THE ACP®215 OPERATOR'S MANUAL. THE CUSTOMER STATED THAT THE LEAKS WERE NOT OBSERVED UNTIL AFTER THEY HAD CENTRIFUGED THE BAGS. THE INTRA-UTERINE TRANSFUSION WAS REQUIRED AS THE MOTHER HAS AN ALLOIMMUNIZATION TO ERYTHROCYTE ANTIGENS WHICH IS PASSED OVER THE PLACENTA AND MAY CAUSE ANEMIA IN THE FETUS. THE TWO BEST MATCHED ERYTHROCYTE UNITS WERE CONTAINED IN THE TWO BAGS THAT LEAKED DELAYING THE TRANSFUSION TO THE FETUS, SO THE GYNECOLOGIST DECIDED TO POSTPONE THE TRANSFUSION BECAUSE THERE WERE NO OTHER COMPLETELY MATCHED UNITS AVAILABLE.