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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*RX15RW40
Device Problem Pressure Problem (3012)
Patient Problem Blood Loss (2597)
Event Date 05/31/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device has not been returned for evaluation. The investigation is currently ongoing. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings. A search of the complaint file found no other report of this nature with the involved product code/lot# combination. (b)(4).
 
Event Description
The user facility reported a high pressure drop in the absence of gas exchange alteration on the involved capiox device. Entered in bypass with patient in ventricular fibrillation, heparin done during fv and it added in the prime (10. 000 u/i). After 10 minutes on by pass with a flow of 4900 ml / min and act higher than 480 there was an increase of oxy inlet pressure (440 mmhg) and a normal outlet pressure (70 mmhg) without alteration of the gaseous exchanges (gas blender fio2 at 60% and 2. 5 l / m of air). All the measures envisaged to decrease the pressure drop (add of albumin and sodium nitroprusside) did not have any results so it was decided to decrease the temperature and replace the oxygenator. Blood loss was reported to be 400 ml. The procedure outcome is unknown. Finla patient impact is unknown.
 
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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
950 elkton blvd
elkton, MD 21921
MDR Report Key7613665
MDR Text Key111470560
Report Number9681834-2018-00107
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier04987350771094
UDI-Public04987350771094
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K071494
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 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberCX*RX15RW40
Device Lot Number170822
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 Received06/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2017
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: 06/19/2018 Patient Sequence Number: 1
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