Brand Name | CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER |
Type of Device | OXYGENATOR, 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 Key | 6303582 |
MDR Text Key | 66667609 |
Report Number | 9681834-2017-00021 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
UDI-Device Identifier | 04987350781772 |
UDI-Public | 04987350781772 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071572 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/06/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2019 |
Device Catalogue Number | 1CX*FX05RW |
Device Lot Number | 160831 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/15/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/09/2017 |
Initial Date FDA Received | 02/06/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/07/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/31/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|