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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

The user facility reported that no anomaly was felt in gas transfer performance during circulation.However, when the circulation ended, it was found that blood was flowing into the gas line.Since it was time to end the circulation, the involved product was continued to use and successfully completed the surgery.There was no harm to the patient.

Manufacturer Narrative

D4: udi no: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: clinical engineer.G4: 510(k) no: k071494, k130520.1.Investigation of the actual sample: 1.1.Visual inspection of the actual sample upon receipt.It was found that blood had been leaked on the gas channel side.1.2.After rinsing the actual sample, leak test was performed with saline solution: it was found that saline solution had been leaked from the gas inlet side.1.3.The actual sample was disassembled, and visual inspection was performed for leaked section: it was found that there was a leak passage on the innermost side of urethane layer.Regarding the leak passage, it was found that a tape was pasted between the urethane and the heat exchanger outer cylinder, and the leak was along the edge of tape.2.Record review: 2.1.The manufacturing record and the shipping inspection record of the actual sample.No anomaly was found in operating conditions of equipment in the fiber winding process.No anomaly was found in 100% leak test result after the oxygenator assembling process.2.2.Past complaint file: no other similar report was found since the launch of capiox rx and capiox fx.3.Cause of occurrence/conclusion: based on the investigation result, as a possible cause of occurrence, it was likely that in the fiber winding process, since the tape used to fix the fiber remained in the urethane-filled part, the urethane was not securely fixed to the heat exchanger outer cylinder, and a leak passage generated.As a possible cause that the tape remained in the urethane-filled part, it was inferred that a part of the tape fixing the fiber was peeled off due to the operator's carelessness.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX CUSTOM PACK
• 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: 17243781
• MDR Text Key: 318583579
• Report Number: 9681834-2023-00125
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX56103
• Device Lot Number: 230130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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