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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT) OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT) OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX15RW30
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/29/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Review of the provided photo and movie showing the reported event revealed that blood was flowing out of the upper part of the venous filter (around 2800ml level of the reservoir); the blood level inside the venous filter was approximately 300ml. The actual sample was received for evaluation. Visual inspection revealed no obvious anomaly, such as a break, in the appearance. In order to evaluate the defoaming performance of the venous filter, the actual sample was rinsed and built into a circuit with tubes, and then circulated with bovine blood at the flow rate of 0 - 4l/min in a manner that the blood level in the reservoir kept at 300ml (the same level as that shown in the provided photo). The reported event was not reproduced in this test. Bovine blood was circulated in the circuit in the manner where air was being suctioned into the venous line. This resulted in flow-out of blood from the upper part of the venous filter. Air mingled into the venous filter is defoamed by the defoamer set inside the venous filter. In this complaint, however, air continued to enter the reservoir continuously, resulting in flow-out of blood from the upper part of the venous filter. The venous filter was disassembled from the actual sample and the tube linked to the venous line was visually inspected. No break or no other anomaly was found in the appearance. Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings. 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 actual sample after having been rinsed did not have any anomaly which could have led to the blood flowing out of the upper part of venous filter. It is likely that air bubbles suctioned into the venous line were accumulated in the venous filter and finally flowed out of the upper part of the venous filter. However, with no reproduction of the reported event achieved during inspection of the actual sample, 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 they did not find anything unusual during priming of the involved capiox device; may be the flow rate was small. When they started cpb, they saw the venous blood out of from the upper side of vr filter and felt venous blood flow was not smooth. They changed the actual reservoir, and everything became normal. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX RX15 W/ 3L RESERVIOR (LT. PORT)
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
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key9509645
MDR Text Key188995475
Report Number9681834-2019-00222
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K051997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberCX*RX15RW30
Device Lot Number190522C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
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