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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCAPIOX FX25 OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key10337263
MDR Text Key203711315
Report Number9681834-2020-00138
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-FX25RWV
Device Lot Number200120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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