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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX25RW
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2017
Event Type  malfunction  
Manufacturer Narrative
It was initially reported the actual device was available for evaluation, however confirmation was received that the sample was no longer available. The actual device was not returned for evaluation. An evaluation of the retention sample was performed. Visual inspection revealed no anomalies. The retention sample was of normal product. With no device return the exact cause of the reported event cannot be definitively determined based on the available information. However, based on the reported state of occurrence, it is possible that the actual sample was exposed to excessive shock force after having been taken out of the box and the oxygenator module then broke. The ifu states: do not use if the package or device is damaged (e. G. Cracked) or any of the port caps are off.
 
Event Description
Additional information was received on january 16, 2018. The oxygenator groove of the actual sample had been broken.
 
Manufacturer Narrative
The actual device has not yet been returned to the manufacturing facility for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no relevant findings. A search of the complaint file found no previous report of this nature with the involved product code/lot number combination. (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 a break in the capiox device. Follow up communication with the user facility confirmed the following information: upon receiving the oxygenator device damaged was noted without opening the package; and there was no patient involvement.
 
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Brand NameCAPIOX RX OXYGENATOR
Type of DeviceOXYGENATOR, 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 Key6961103
MDR Text Key250439620
Report Number9681834-2017-00225
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K040210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue NumberCX*RX25RW
Device Lot Number170323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2017
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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