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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRY20601
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
Udi number for this product code is not required.The actual device was discarded by the involved facility.Therefore the investigation was limited to the information provided by the user facility as well as a photo provided by the user facility.The photo taken during the use of the actual device.The following findings were obtained by the photo.A blood leak was noted at the joint of the tube and the blood outlet port on the oxygenator module.The tube seemed to have been inserted over the port all the way sufficiently with no obvious anomalies noted on the shrink tube attached to the joint.A review of the device history record from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lo number combination.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, the following factors can be inferred.Due to some factor(s), such as a way of tube handling, the segment of the tube around the joint between the tube and the port was subjected to some bending force.By this force, the tube slipped off the port slightly and the sticking force acting between the tube and the port was degraded, resulting in the generation of a channel of a leak.The segment of the blood outlet port covered with the shrink tube had some anomaly such as a crack, resulting in the reported leak.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported leakage in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: a blood leak was noted at the joint between the tube and the blood outlet port on the oxygenator module; the customer found the leak soon before the completion of the extra corporeal circulation and decided not to change out the device; the procedure was finished using the actual device; and blood loss was approximately 2 cc.
 
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Brand Name
CAPIOX FX OXYGENATOR
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA  418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA   418
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6833481
MDR Text Key84098388
Report Number9681834-2017-00180
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 08/31/2017
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 Date09/30/2018
Device Catalogue NumberCX-XRY20601
Device Lot Number170406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/03/2017
Initial Date FDA Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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