CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET LEAKED AT THE "NON-RETURN VALVE POINT". THIS WAS OBSERVED WHEN THE NURSE WAS MONITORING THE PATIENT DURING A RED BLOOD CELL TRANSFUSION. THE INFUSION WAS STOPPED, AND THE SET WAS CHANGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER POSTAL CODE: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

H4: THE LOT WAS MANUFACTURED IN SEPTEMBER 2023. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO PHOTOGRAPHS OF THE ACTUAL SAMPLE AND RETAINED SAMPLES WERE EVALUATED. THE SAMPLE PHOTOS UNDERWENT VISUAL INSPECTION WHICH SHOWED BLOOD IN THE TUBING; HOWEVER, NO ISSUES OR LEAKS WERE IDENTIFIED. THE REPORTED CONDITION COULD NOT BE VERIFIED ON THE ACTUAL SAMPLE. VISUAL INSPECTION OF RETAINED SAMPLES DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL GRAVITY TESTING IN THE LABORATORY VIA METHYLENE BLUE AND UNDERWATER LEAK TESTS WERE PERFORMED; NO LEAKS WERE IDENTIFIED. THE REPORTED CONDITION WAS NOT VERIFIED ON THE RETAINED SAMPLES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.