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Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, H6 AND H11. B5: UPON ADDITIONAL INFORMATION, THE INITIAL REPORTER FURTHER STATED "THEY PERFORMED RESEARCH AND IT WAS FOUND THAT THE REPORT OF CLOTS IN THE BLOOD SET HAD NO IMPACT ON THE COMPARTMENT SYNDROME". H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A PATIENT DEVELOPED COMPARTMENT SYNDROME DUE TO CLOTS OBSERVED IN THE FILTER OF A Y-TYPE BLOOD SOLUTION SET. ON THE DAY OF THE EVENT, THE PATIENT RECEIVED A BLOOD TRANSFUSION AND ¿BLOOD CLOTS¿ WERE OBSERVED ¿DURING TRANSFUSION IN THE FILTER OF THE BLOOD TUBING¿. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT DEVELOPED COMPARTMENT SYNDROME ¿IN AN EXTREMITY¿. ADDITIONALLY, THE FACILITY INQUIRED ABOUT "WHAT IS THE MAXIMUM AMOUNT OF BLOOD THAT CAN GO THROUGH THE FILTER, BEFORE IT SHOULD BE EXCHANGED"? NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.