FDA Adverse Event
Summary report: N
CENTRISOL
MDR report key: 8922841
·
Received August 21, 2019
Report
- Report Number
- MW5089254
- Date Received
- August 21, 2019
- Report Date
- August 21, 2019
- Manufacturer
- MEDIVATORS INC.
- Product Code
- FKQ
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE FOLLOWING DIALYSIS FLUIDS LOOK EXTREMELY SIMILAR AND HAVE POOR USE OF COLOR ON THE LABEL TO DIFFERENTIATE PRODUCTS. THE LABELS SHOULD USE A LESS DISTRACTING COLOR AND DIFFERENTIATE CONCENTRATIONS OF ELECTROLYTES. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712763 | CENTRISOL | SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT | FKQ | MEDIVATORS INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |