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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 1CX*FX05RW
Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation. A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent. A review of the device history records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings. A search of the complaint file found no other report with the involved product code/lot# combination. See mdr no. 9681834-2017-00021 for the second device reported in this complaint. (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 two damaged capiox devices when removing from the damaged packages. Follow up communication with the user facility reported the following information: there was no patient involvement.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide the returned sample evaluation; provide the device return date in device available for evaluation. The actual device was returned to the manufacturing facility. Visual inspection revealed that the top side of the shipping cardboard box in which the actual samples were packed had been damaged. The shipping cardboard box was opened. One of the top lids that had been broken off its place was found to have been put on the top of the unit boxes packed in the shipping box. The broken top lid was removed. It was revealed that the two unit boxes set on the upper stage were found to have been broken on the top side. The two unit boxes set on the lower stage were confirmed to have no damage on them. Each product was unpacked from the unit box for further visual inspection. All four devices were confirmed to have no anomaly or breakage. From the state of damage observed on the boxes, it is likely that the actual sample was exposed to some load during transportation and became damaged. There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined. The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e. G. Cracked) or any of the port caps are off. " all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
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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, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6303577
MDR Text Key66621745
Report Number9681834-2017-00003
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number1CX*FX05RW
Device Lot Number160831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
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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