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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX21501
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- clinical engineering. Pma/510(k)- k130520. The actual sample was received for evaluation. Visual inspection revealed no breakage or other external anomalies. Air was blown into the gas channel of the actual sample. A pinkish liquid was observed to flow out. The liquid was collected, centrifuged, and some deposit was observed. The deposit was checked with a laser microscope and found to be a type of bacteria. The actual sample, after having been rinsed and dried, was filled with colored physiological saline solution, and then tested for leakage by air of 2kgf/cm2 being applied. No leak was observed. From this, it was presumed that there were no anomalies that could lead to the leak such as a cut in the fiber. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Performance test results of the fiber lot used in the involved product code/lot product was confirmed to meet the factory's control criteria. Ifu states: do not use this product for a period in excess of six hours. Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance. Do not use an oxygenator and reservoir that leaks. Replace it with another capiox fx25 oxygenator and reservoir. 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 investigation results verified the returned sample was of normal product. As a cause of the plasma leak, it was likely that due to a change in the blood properties, a surface-active substance may occur in blood and disrupt the balance, which is maintained in the micropores of the fiber, between the surface tension of blood and the gas pressure. Such condition may lead to plasma leak. In particular, for the patients with renal / hepatic failure, plasma leak tends to occur in a shorter time. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported the capiox custom pack was used during the procedure. During operation, after three or four hours, a suspected plasma leak occurred. During gas flush, a significant amount of suspected plasma leak was observed. When it occurred, there was also a decrease in oxygenation performance, which was coped with increasing fio2. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX CUSTOM PACK
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
mary o'neill
reg. no. 2243441
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key12437734
MDR Text Key270306483
Report Number9681834-2021-00151
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 Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Catalogue NumberCX-XRX21501
Device Lot Number201221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2020
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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