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

Catalog Number CX-FX25E

Device Problem Leak/Splash (1354)

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

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation- clinical engineer.Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection of the luer thermistor revealed no break, deformity, or other obvious anomaly that could lead to the leak.Blood was found adhering to the end of the tube connected to the bcp port.The actual sample was connected to a circuit with tube, filled with normal saline (colored for better visibility), and then circulated at 3000 rpm with a centrifugal pump.As a result, no leak occurred.Then, the tube attached to the bcp port was squeezed with fingers.As a result, leak occurred.The bcp port after separated from the tube was inspected under a magnifier.No deformity or no other obvious anomaly was observed.Compared to a current product sample, no difference in the outer diameter was observed.The actual sample after rinsed was connected to a factory-retained tube, the blood channel was filled with normal saline, and the blood outlet port side was blocked with forceps.Then, the actual sample was pressurized at 2kgf/cm2 from the blood inlet port side for six hours.As a result, no leak 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.Ifu states: band all connections in the circuit.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the blood leaked at the bcp port connection area and reached the luer thermistor section.However, 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 device was used pre-treatment.Priming solution was found leaking at the luer thermistor section.The actual sample was exchanged with another oxygenator.The patient was not harmed.The procedure outcome was not reported.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11063876
• MDR Text Key: 223368237
• Report Number: 9681834-2020-00262
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: CX-FX25E
• Device Lot Number: 200618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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
• Patient Outcome(s): Other