MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-RX25RW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A picture of the actual sample was provided and revealed that the lock adapter on the red switch cock side of the three-way stopcock had been detached.No obvious deformity or break was observed in the appearance of the actual sample.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history records and the shipping inspection record.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.It is likely that the male connector surface was slippery due to being wet with drug solution.When the lock adapter was tightened, it came off the male connector that was in the slippery state; or the silicon applied to the switch cocks of the three-way stopcock was transferred to the male connector part when the sampling system components were put in a container for storage during manufacturing.Afterward, when the lock adapter was tightened, it came off the male connector that was in the lubricated state.However, with no return of the actual device, 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 during set-up the involved capiox device circuit, the user jointed a shunt tube to the red switch cock side of the three-way stopcock and attempted to tighten the lock connector.However, it was just spinning and did not stop, so they could not tighten it.They said they did try and tighten as usual and did not apply force when rotating.The event occurred pre-treatment.

• Brand Name: CAPIOX RX25 OXYGENATOR/RESERVOIR
• 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: 9670574
• MDR Text Key: 205520938
• Report Number: 9681834-2020-00001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040210
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-RX25RW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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