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

Catalog Number CX-XRZ27702

Device Problem Air/Gas in Device (4062)

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

Event Date 05/31/2021

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 no anomaly, such as a breakage or deformation, which could cause air to be drawn in it. The actual sample was rinsed and dried, the venous and arterial lines were clamped, and then normal saline was circulated through the recirculation line at 1 l/min for one hour. As a result, no air was drawn. The normal saline was colored for better visibility, the one-touch clamp of the recirculation line was released while the recirculation line was blocked with forceps. The pressure applied to the oxygenator was measured and revealed: when the liquid level of the drainage line was higher than the position of the blood outlet port of the oxygenator, the pressure applied to the oxygenator became positive and the liquid level of the drainage line was not lowered. When the liquid level of the drainage line was at the same level as the blood outlet port, the pressure applied to the oxygenator became 0 mmhg and the fluid level of the drainage line was not lowered. When the liquid level of the drainage line was lower than the blood outlet port, the pressure applied to the oxygenator became negative and the liquid level of the drainage line was lowered. In addition, as the liquid level dropped, the head became high causing the negative pressure to the oxygenator to increase, leading to air drawn in through the fiber. Rotation with a roller pump was performed. As a result, the fluid inside the reservoir was discharged with no problem. The phenomenon of the complaint where the fluid in the reservoir was not discharged was not reproduced. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Ifu states: ensure the oxygenator is never subjected negative pressure. Negative pressure in the oxygenator can cause gaseous emboli to enter the blood phase from the gas phase. 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. The cause of this issue was thought to be that when the drainage line was opened, the liquid level of the drainage line was located lower than the blood outlet port of the oxygenator, which caused negative pressure to be applied to the oxygenator and air to be drawn in through the fiber. The exact cause of the reported event cannot be definitively determined based on the available information. Terumo medical products (tmp) (importer) registration no. (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. (b)(4).

Event Description

The user facility reported that the capiox custom pack was used pre-treatment. After rinsing with 5% dextrose, the actual sample was built into circuit. After circulation, normally, when the one-touch clamp in front of the drainage line to be added to the recirculation is released, and then the main pump is on, the fluid is discharged from the reservoir; however, just after the clamp was released, air was drawn in the oxygenator, and the fluid in the oxygenator was discharged completely. Turning the main pump immediately could not discharge fluid from the reservoir. The pump was stopped, and the circuit was replaced before the surgery started. The surgery was completed without any problems. The patient was not harmed. 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: mary o'neill ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 12082478
• MDR Text Key: 258875383
• Report Number: 9681834-2021-00103
• 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,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CX-XRZ27702
• Device Lot Number: 210311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial