FDA Adverse Event
Malfunction
Summary report: N
CENTRISOL ACID CONCENTRATE
MDR report key: 20109031
·
Received August 29, 2024
Report
- Report Number
- MW5159069
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Report Date
- July 23, 2024
- Manufacturer
- MEDIVATORS INC.
- Product Code
- FKQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
CONCERN ABOUT LOOK ALIKE LABELS FOR DIALYSIS ACID SOLUTIONS FROM OUTSET MEDICAL. THE 2K AND 3K ACID BATHS HAVE THE SAME WHITE WRITING ON OTHERWISE IDENTICAL RED BACKGROUND LABELS. IT WOULD BE EASY TO MIX UP THE SOLUTIONS DURING STORAGE AND CREATE A POSSIBLE ERROR. I HAVE SENT AN EMAIL THE TABLO OUTSET WITH OUR CONCERNS AS WELL. CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(4) IS A FEDERALLY CERTIFIED PATIENT SAFETY ORGANIZATION AND AD FDA MEDWATCH PARTNER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1369499 | CENTRISOL ACID CONCENTRATE | SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT | FKQ | MEDIVATORS INC. | SB-352 | 591951 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |