Brand Name | LIBERTY CYCLER UL |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
Manufacturer (Section D) |
CONCORD MANUFACTURING |
director, quality systems |
4040 nelson avenue |
concord CA 94520 |
|
Manufacturer (Section G) |
CONCORD MANUFACTURING |
director, quality systems |
4040 nelson avenue |
concord CA 94520 |
|
Manufacturer Contact |
jessica
trujillo
|
920 winter st |
waltham, MA 02451
|
6174175172
|
|
MDR Report Key | 15520878 |
MDR Text Key | 301009395 |
Report Number | 0002937457-2022-01631 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123630 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/30/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNKNOWN- LIBERTY CYCLER UL |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | MO |
Initial Date Manufacturer Received |
09/06/2022 |
Initial Date FDA Received | 09/30/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | DELFLEX PD FLUID; LIBERTY CYCLER SET |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|