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

Catalog Number CX-CR10NX

Device Problem Obstruction of Flow (2423)

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

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product release decision control sheet of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Ifu states: "adequate heparinization of the blood is required to prevent it from clotting in the system.(general precautions).Do not reduce heparin during circulation.Otherwise, blood clotting might occur.(general precautions)" based on the investigation result, no anomaly was found in the manufacturing record.As a cause of occurrence, since the event occurred approximately six hours after the start of extracorporeal circulation, it was likely that clots were generated during circulation due to the blood properties of the patient at the time of use, and the filter was obstructed.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 approximately six hours after the start of extracorporeal circulation, obstruction of the filter began to occur.Therefore, the product was replaced with a new one.The patient was not harmed.

• Brand Name: CAPIOX CARDIOTOMY 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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 13530192
• MDR Text Key: 287895997
• Report Number: 9681834-2022-00005
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-CR10NX
• Device Lot Number: 210914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Patient Outcome(s): Other