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

Model Number N/A

Device Problems Fracture (1260); Gas/Air Leak (2946)

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

Event Date 07/13/2022

Event Type  malfunction  

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - clinical engineer.Pma/510(k)- k071572, k130280.The actual device has been returned for evaluation.Visual inspection of the actual sample as received found that the port of the sampling system where the yellow three-way stopcock was located had been fractured at the base.The blue three-way stopcock had been dislodged from the mount.Magnifying inspection of each fracture surface found that the fracture surfaces were smooth overall, with a striated pattern observed starting from the mount side.No elongation of material was observed.From this, it was inferred that fractured was caused by some kind of instantaneous force.It is known from our experience that when a diagonal upward force is applied to the l- connector connected to the blue three-way stopcock side of the sampling system, bending force may be exerted to the three-way stopcock and a break similar to the actual sample may occur.Review of the manufacturing record and the product-release judgement record of the involved product code/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the involved product /lot number combination.Based on the investigation result, as a cause of this complaint, it is conceivable that some instantaneous force was applied to the three-say stopcock, which resulted in the fracture.However, from the state of the actual sample, it was not clarified when such force was applied to the actual sample.Relevant ifu reference: " do not use if the package or device is damaged(e.G.Cracked) or any of the port caps are off." " 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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the during priming the involved capiox device, it was found that sampling system was leaking medical fluid.Upon checking it was found that the area between the blue and yellow cocks of sampling system had been fractured.The sampling system only was replaced, and the product was used continuously.The procedure was completed successfully.The final patient impact was not harmed.The event occurred pre-treatment.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15135856
• MDR Text Key: 304358607
• Report Number: 9681834-2022-00152
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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-FX25REV
• Device Lot Number: 220131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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