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

Catalog Number CX-XRX14702

Device Problem No Device Output (1435)

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.Address: (b)(6).Occupation: clinical engineer.Pma/510(k): k130520.The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted.Review of the picture provided by the user facility revealed that a circuit from other brand was connected to the gas-out port of the actual oxygenator.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 description of the event that the oxygenator in question was not changed out and used as it was, it was presumed that oxygenation was performed properly, therefore it was likely that there was not any anomaly in the gas channel.As a cause that etco2 could not be measured, the amount of gas flowing toward the gas outlet might have been small due to some factors during use.However, with no device return 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 during the procedure.Etco2 could not be measured during on-pump; usually, it can be measured with no problem.Dräger reacted when they blew on it, so it seemed not to attributable to the measuring instruments.It was judged that there was no problem in the actual use of the product in question, and it was used as it was.The procedure was completed successfully.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: 11054556
• MDR Text Key: 223163807
• Report Number: 9681834-2020-00258
• 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: 12/22/2020

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: 08/31/2021
• Device Catalogue Number: CX-XRX14702
• Device Lot Number: 200312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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
• Treatment: DRÄGER; S5