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

Catalog Number CX-CRX59601A

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Udi not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.Pma/510(k): k130520.The actual sample was received for evaluation.Visual inspection revealed that the sampling line tube was torn at the joint to the blood outlet port.No other obvious anomaly was noted.Normal saline was flowed into the actual sample.A leak was confirmed at the torn section of the sampling line tube.Magnifying inspection of the area around the torn section of the sampling line tube revealed that the tube had been cracked partially and some of the cracks went through the tube wall.Electron microscopic inspection of the torn section of the sampling line tube found a circular damage penetrating the tube wall, and some streaks were observed on the damaged surface.In addition, the port to which the sampling line tube was glued was found to have been deformed.Based on this, it was likely that the actual sample came into contact with a hard object with resultant generation of tear on the tube.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: 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 was likely that the leak occurred through the damage generated at the joint of the sampling line tube to the blood outlet port.It is likely that the damage was caused due to a hard object having come into contact with the tube.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 custom pack was used pre-treatment.Upon completion of priming, the actual sample was brought in the operation room.During preparing other equipment, they found a leak at the joint of sampling line to the blood-out port.They stop using the actual sample, and changed out the oxygenator and the reservoir.There was no harm to patient the health.The procedure outcome was not reported.

• Brand Name: CAPIOX CUSTOM PACK
• 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 08873 ; 8002837866
• MDR Report Key: 11063806
• MDR Text Key: 223461262
• Report Number: 9681834-2020-00257
• 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: 12/23/2020

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 Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Catalogue Number: CX-CRX59601A
• Device Lot Number: 200605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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