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

Model Number N/A

Device Problem Output Problem (3005)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

The user facility reported that the blue thermistor probe cable was attached to the thermistor probe at the venous blood port of the reservoir in the usual manner, however the venous blood-side temperature was not displayed on ccm of aps1.(the temperature at the outlet of oxygenator was read with red one).As there was a possibility that the blue temperature probe cable was malfunctioning, the red one was connected to the venous blood side, however no change was observed.The temperature on the venous blood side was not read while the pump was on.The surgery was completed successfully.After the pump was turned off, when another thermistor probe (a single item) was attached to the venous blood port of the reservoir, and the temperature was displayed on the ccm.There was no patient injury/medical or surgical intervention required.The procedure was completed successfully.There was no harm to the patient.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi: 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.E1: establishment name:(b)(6) hospital.E3: occupation: clinical engineer.G4: pma/510(k): k130520.Visual inspection of the actual sample upon receipt found no anomaly such as damage.The actual sample was cleaned, and a factory retained thermistor probe cable was connected to the thermistor probe glued to the venous port of the reservoir.It was confirmed that temperature could not be read.The thermistor probe in question was examined under x-ray fluoroscopy.It was confirmed that one of wires inside was broken.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar event was reported.Based on the results of the investigation, it was likely that the temperature was not read during use because the wire inside the thermistor probe was fractured.The thermistor probe is subjected to in-process 100% continuity check; therefore, it was likely that some external force was applied to the actual sample during handling after the manufacturing process of the thermistor probe, which resulted in the fracture of wire inside.However, the cause could not be clarified.Relevant instructions for use (ifu) reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." 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 OXYGENATOR
• 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 ; 4103927218
• MDR Report Key: 18408754
• MDR Text Key: 331486683
• Report Number: 9681834-2023-00257
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX64202
• Device Lot Number: 230619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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
• Treatment: APS1.