MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25RWV

Device Problem Obstruction of Flow (2423)

Patient Problem Blood Loss (2597)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection revealed no visible anomaly.Compared to a current product sample, it was found that cardiotomy filter had been swelled.Visual inspection of the lid of the reservoir revealed that blood was adhered up to the upper end of the cardiotomy filter.The cardiotomy filter and the defoamer inside it were submerged in physiological saline solution, and then inspected visually.Formation of blood clots was observed on some parts; however, it was confirmed there was no anomaly that could cause clogging of the reservoir in the remainder part.The cardiotomy filter and the defoamer inside it were rinsed, then some parts with no adhesion of blood clots were inspected with sem.No difference was confirmed compared to those of a current product sample.A review of the device history record and the product release judgement record of the involved product code/ lot # combination was conducted with no findings.The cause of the clogging could not be read by reviewing the pump record.Ifu states: the caps of unused ports should be left in place.This avoids contamination and prevents leakage of blood.Make sure the caps of unused luer ports are tightened firmly to prevent the leakage.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 the normal product.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 fx25 was used during the procedure.Left atrium myxoma case.During ecc the cardiotomy part of the venous reservoir was clogged, the reservoir level reached the highest, and the blood in the reservoir temporarily overflowed.During the ecc, act decreased to 350, and heparin was added to improve it to 490.They used the cell saver blood reservoir and the vein soft reservoir urgently to maintain the ecc and managed to turn off the pump.The operation finished safely.The estimated blood loss was 200ml.The patient was not harmed.The procedure outcome was successful.

• Brand Name: CAPIOX FX25 OXYGENATOR
• 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; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 10337263
• MDR Text Key: 203711315
• Report Number: 9681834-2020-00138
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 200120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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