MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX05 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Break (1069)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

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.E3: occupation: clinical engineer.G4: pma/510(k): k130280.Visual inspection of the actual sample found that the thermistor probe on the reservoir had been damaged at the base.Magnifying inspection of the damaged surface of actual sample found no elongation.Therefore, it was suggested that the involved section may have been damaged due to momentary force.No foreign substance kneading that could lead to damage was found.Electron microscopic inspection of the damaged surface of actual sample found that the damaged surface was smooth.Simulation test: based on the condition of the damaged surface of actual sample, assuming that the product would be damaged by momentary force, momentary force was applied to the factory-retained sample.As a result, a form of damage similar to the actual sample was simulated.The manufacturing history record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, as a possible cause of occurrence, it was inferred that a momentary impact load was applied to the thermistor probe, leading to the damage.However, from the condition of actual sample, it was not possible to clarify exactly when it was damaged.Relevant instructions for use (ifu) reference: "if the product is dropped during set-up, do not use it.Replace with another device." 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 that after opening the package, it was discovered that the thermistor probe on the reservoir was damaged.The product was used during the surgery, and the procedure was completed successfully.The final patient impact was not harmed.There was no medical/surgical intervention required.

• Brand Name: CAPIOX FX05 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 ; 6402040886
• MDR Report Key: 18046583
• MDR Text Key: 327047959
• Report Number: 9681834-2023-00215
• 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: 11/01/2023

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 Model Number: N/A
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 230406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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