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, 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 |
950 elkton blvd. |
elkton, MD 21921
|
8002837866
|
|
MDR Report Key | 13224830 |
MDR Text Key | 287897976 |
Report Number | 9681834-2021-00262 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
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 |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/11/2022 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 01/11/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | CX*FX05RE |
Device Lot Number | 191121 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/26/2022 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/26/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/21/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|