MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRY36801

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)- k130520.The actual sample was a thermistor probe, which had been cut off the main body by the customer was received for evaluation.Visual and magnifying inspections revealed that the thermistor probe had been twisted and torn off at the glued section to venous blood inlet port.Some traces that seemed to have caused when the thermistor probe was pinched with forceps were observed on the outer surface.Any anomaly that could obstruct the normal connection, such as residue of glue or defective molding, was not found.An attempt to connect the actual sample to a factory-retained thermistor probe cable was made.It was demonstrated that the actual sample was inserted in the thermistor probe cable to the same position that a current product sample was inserted.A review of the device history record and product release decision control sheet of the involved product code/lot number 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 demonstrated that it was possible to insert the factory-retained thermistor probe cable to the actual sample normally.Since the actual sample was cut off the venous blood inlet port by the customer, the actual condition of the actual sample during the event was unable to be confirmed.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the capiox device issue was found during setup.The thermistor probe cable would not fully fit into the thermistor probe connected to the venous blood inlet port.The temperature could be read, and they continued using it.There was no procedure outcome reported.There was no harm to the patient.The event occurred pre-treatment.

• Brand Name: CAPIOX FX15
• 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; 950 elkton blvd.; elkton, MD 21921
• MDR Report Key: 9569932
• MDR Text Key: 181588229
• Report Number: 9681834-2019-00233
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CX-XRY36801
• Device Lot Number: 191001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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