CAPIOX FX25

Description of Event or Problem

Terumo received the following information. It was reported that the Oxygenator was clogging. There were no issues observed during priming with Ringer's solution. During cardiopulmonary bypass, while performing the proximal anastomosis in two sections, 600 mL of blood was suctioned into the oxygenator. The heparin dose had been reduced for approximately 1.5 hours; the activated clotting time (ACT) was reported as 370, and approximately 8,000 cc of heparin had been administered. The oxygenator was subsequently replaced with an oxygenator manufactured by SENKO MEDICAL INSTRUMENT Mfg. Upon removal, blood clots were observed to have immediately adhered to the affected oxygenator. The procedure outcome was not reported. The patient was not harmed.

Additional Manufacturer Narrative

A1: Patient Identifier: NA.A2: Age & Date of Birth: NA.A3a: Sex: NA.A4: Weight: NA.A5: Ethnicity: NA.A6: Race: NA.D6a: Implanted Date: Device was not implanted.D6b: Explanted Date: Device was not explanted.E3: Occupation: Clinical Engineer.G4: 510(k) No.: K130520.The actual device was not available; therefore, the actual device will not be returned for evaluation. There was no anomaly found in the manufacturing record and the shipping inspection record of the actual device. There was no similar report with the involved product code/lot number in the past complaint file.The reported increase in pressure loss was likely associated with blood clot formation and subsequent obstruction within the oxygenator. As the actual device was not available for evaluation, the root cause of the event could not be confirmed.Relevant IFU Reference: Do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system.Terumo Medical Corporation (TMC) (Importer) Registration No. 2243441 is submitting this report on behalf of Ashitaka Factory of Terumo Corporation (Manufacturer) Registration No. 9681834.