BLOOD RECIPIENT SET

Additional Manufacturer Narrative

THE EVENTS WERE OBSERVED SINCE MAY 2025. D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. E1: INITIAL REPORTER PHONE NO.: (B)(6). H11: THE ACTUAL DEVICES WERE NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF A SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTO SAMPLE SHOWED EVIDENCE OF A BLOOD PRODUCT LEAK WHICH APPEARS TO BE AT THE CONNECTION OF TWO SETS (GAUZE IS WRAPPED AROUND THE CONNECTION). THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF Y-TYPE BLOOD/SOLN SETS LEAKED WHILE IN USE WITH NON-BAXTER CASSETTES ON A WARMING DEVICE. THIS WAS OBSERVED DURING BLOOD TRANSFUSIONS WITH RED BLOOD CELLS UNDER PRESSURE (AROUND 150-200 MMHG). THE LEAK LOCATION WAS IDENTIFIED AT THE CONNECTION BETWEEN THE SETS AND NON-BAXTER CASSETTES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.