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

Catalog Number CX-CRX05101A

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual device including the luer thermistor was received for evaluation.Visual inspection revealed no break or any other anomaly in the appearance.The actual sample after rinsed was built into a test circuit and circulated with 37°c-temperature water, and the temperature-reading accuracy of each luer thermistor was evaluated.The reading accuracy of all the thermistor was confirmed to meet the manufacturer specifications and no anomaly was observed.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox custom pack was used pre-treatment.During a priming with the temperature set to 36°c, the venous blood temperature was shown as 35.5°c whereas the arterial temperature was shown 34.7°c - 35.2°c.This phenomenon occurred after the s5 module was changed.They stopped using the actual sample and prepared a replacement to continue the case.The procedure was completed successfully.There was no harm to the patient.

• Brand Name: CAPIOX FX 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: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 10137112
• MDR Text Key: 214801594
• Report Number: 9681834-2020-00088
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CX-CRX05101A
• Device Lot Number: 190911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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