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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number CX*HC11L
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Information (3190)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device has been returned 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 product release decision control sheet of the product code/lot# combination was conducted with no findings. This report is for the first device reported, for the second device reported that was used on the same patient see mdr 9681834-2019-00235. (b)(4).
 
Event Description
The user facility reported that the capiox hemconcentrator was stuck and there was no function during bypass after two hours. They changed out the device to a new one to allow the procedure to keep going until the end. The procedure outcome and patient impact was reported to be unknown.
 
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Brand NameCAPIOX HEMOCONCENTRATOR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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
265 davidson ave, suite 320
somerset, NJ 08873
8002837866
MDR Report Key9606473
MDR Text Key202724936
Report Number9681834-2019-00239
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K973516
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,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberCX*HC11L
Device Lot Number190510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2019
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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