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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX45403
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k-) k130520. The actual device was not returned for evaluation and was discarded by the involved facility, however a photographs of the actual sample were provided. A review of the provided photos showing the actual sample confirmed the customer's complaint. The support arm was noted to have come off. A photograph of the actual reported product code/lot combination kept after the assembling process was reviewed. The support arm was confirmed to be securely fixed to its correct position. Functional testing was conducted. A test sample packed in the shelf box was dropped in free fall from 2-meter high with the bottom side of the box facing to the ground. Subsequently, the box was opened to check the state of the support arm. The support arm was found to have come off the reservoir being similar to the actual sample. A review of the device history record from the reported product code/lot number combination was conducted with no findings. A search of the complaint file found no previous report of this nature with the involved product/lot# combination. There is no evidence that this event was related to a device defect or malfunction. Although the exact cause cannot be determined, based on the investigation it is likely that the actual device was exposed to excessive shock force at some time after the assembling process before being unpacked, resulting in the reported damage. The ifu states: "this device is sterile and non-pyrogenic in the unopened, undamaged package. Inspect the device and package carefully. Do not use if the package and/or device is damaged, or if caps are not in place. " (b)(4).
 
Event Description
The user facility reported that the oxygenator module had been separated from the reservoir in the unopened bag when taking out of the box and was found pre-treatment. The actual device was taken out of the bag and found that the supportive arm had come off the reservoir. It was fixed back to the original state and the device was used. There was no patient involvement. Procedure outcome is unknown. Final patient impact is unknown.
 
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Brand NameCAPIOX FX 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
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key7351854
MDR Text Key103091315
Report Number9681834-2018-00031
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
Type of Report Initial
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberCX-XRX45403
Device Lot Number161006
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 Received02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2016
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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