MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX25; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: catalog number: unknown.D4: lot number: unknown.D4: expiration date: unknown due to unknown catalog number and unknown lot number.D4: udi no: di number cannot be confirmed since the involved product code and lot# are unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: others.G4: 510(k) no: k071494, k130520.H4: device manufacture date: unknown due to unknown catalog number and unknown lot number.The actual sample was discarded by the involved facility.Record review: the manufacturing record and the shipping inspection record of the actual product: as the product code and lot# were unknown, it was not possible to investigate.Past complaint file: as the product code and lot# were unknown, it was not possible to investigate.Manufacturing date: unknown.Cause of occurrence/conclusion: based on our experience, the following factors could have combined to cause the reported issue; however, the actual product could not be confirmed, and the cause of occurrence could not be clarified.Our reservoir is designed to structurally stabilize the liquid surface of blood stored in the reservoir in order to make it easier to manage the liquid level.On the other hand, the reservoir has a characteristic that makes it difficult to agitate the blood inside the reservoir.Blood with activated blood-clotting factor flowed into the reservoir and accumulated at the liquid level, resulting in the formation of blood clots.Relevant instructions for use (ifu) reference: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings).Adequate heparinization of the blood is required considering patient condition and perfusion technique to prevent it from clotting in the system.(warnings)".Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported blood clotting.While on cpb the perfutionist observered the clot in the oxygenator reservoir.The oxygenator was not replaced and the procedure was continued as normal.No event was reported.The procedure outcome was not reported.There was no harm to the patient.

• Brand Name: CAPIOX FX25
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17343163
• MDR Text Key: 319510777
• Report Number: 9681834-2023-00141
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 60 KG