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

Catalog Number CX-XRX06402

Device Problem Leak/Splash (1354)

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

Event Date 11/19/2020

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 confirmed the absence of breakage in it.It was confirmed that liquid was accumulated in the water channel as reported.The liquid was collected for sem-edx analysis.As a leak test, the blood channel of the actual sample was filled with colored water, blocked at the blood-outlet side, and then pressurized at 2 kgf/cm2 from the blood-inlet side.As a result, no leak was observed.As another leak test, the water channel of the actual sample was filled with colored water, blocked at the water-outlet side, and then pressurized at 3 kgf/cm2 from the water-inlet side.As a result, no leak was observed.The liquid collected from the actual sample was air-dried, and the deposit was analyzed by sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).The result showed that the composition of the liquid was similar to that of tap water.From this, it was presumed that the liquid found in the water channel side was not that leaked from the blood channel side.A review of the device history record and product-release judgement record 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 normal product.It is likely that water went into the water channel during the setup of the circuit due to some factors.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.After priming, when going to attach a coupler to heat exchanger they found a small amount of liquid accumulated in the water-in port.Although cardioplegia line (cx-xp06401) and shunt sensor (cv-510h1) had been attached already, the circuit was changed out.The operation was finished with no problem.The procedure outcome was successful.The patient was not harmed.

• 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: 10964934
• MDR Text Key: 221275028
• Report Number: 9681834-2020-00243
• 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: 12/08/2020

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: 12/31/2021
• Device Catalogue Number: CX-XRX06402
• Device Lot Number: 200720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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