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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RE
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Health professional- requested, not provided. Occupation-requested, not provided. 510(k) no: k130280. The actual sample was received for evaluation. Visual and magnifying inspections of the actual sampling line tube sample upon receipt revealed damage that appeared to have been cut diagonally. Magnifying and electron microscopic inspections found that the cut surface was smooth. Reproductive testing was performed using factory-retained tubing. A test sample was cut with a sharp-edged tool in one direction. The cut surface was smooth, which was similar to the state of damage on the actual sample. A test sample was cut with scissors. The cut surface was smooth, but not the same as the state of damage on the actual sample. A test sample was pinched with the bottom part of forceps. The surface of the pinched area was rough and not similar to the state of damage on the actual sample. Based on the above test results, it is likely that a sharp-edged tool came into contact with the actual sample causing the damage on it. A review of the production process of the sampling line tube was reviewed. It was confirmed that sharp-edged tools are used in tube cutting process, however, it was confirmed also that 100% leak test is performed after the sampling line assembling process. In addition, in the oxygenator assembling process after the 100% leak test, no sharp-edged tools are used. A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings. Ifu states: do not use if the package or device is damaged (e. G. Cracked), or any of the port caps are off. Do not use an oxygenator that leaks. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. It is likely that the actual sampling line tube came into contact with a sharp-edged tool, resulting in the generation of the cut on it. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported that there was a cut/hole on the tubing of the sample port of capiox oxygenator. The event occurred pre-treatment.
 
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Brand NameCAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
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
theresa mussaw
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
4103927866
MDR Report Key9509644
MDR Text Key219763297
Report Number9681834-2019-00216
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue NumberCX*FX05RE
Device Lot Number190125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2019
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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