FDA Adverse Event
Malfunction
Summary report: N
TABLO CARTRIDGE
MDR report key: 20913663
·
Received December 10, 2024
Report
- Report Number
- MW5163504
- Event Type
- Malfunction
- Date Received
- December 10, 2024
- Date of Event
- December 2, 2024
- Report Date
- December 5, 2024
- Manufacturer
- OUTSET MEDICAL INC.
- Product Code
- FJK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A SLED TREATMENT WAS INITIATED FOR AN ICU PATIENT REQUIRING CRITICAL FLUID REMOVAL DUE TO SUSPECTED THIRD SPACING. APPROXIMATELY 2-3 MINUTES INTO THE TREATMENT, A BLOOD LEAK WAS DETECTED, AND A TRAIL OF BRIGHT RED BLOOD WAS OBSERVED AROUND THE SALINE LINE INTO THE CARTRIDGE. THE TREATMENT WAS IMMEDIATELY STOPPED, RESULTING IN A LOSS OF ABOUT 300CC OF BLOOD, AND A KINK WAS NOTICED ON THE CARTRIDGE SET. OUTSET MEDICAL INC WAS CALLED AND TECHNICIAN DIAGNOSED DEFECTIVE CARTRIDGE. DEVICE WAS LATER CLEARED FOR USE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415045 | TABLO CARTRIDGE | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | FJK | OUTSET MEDICAL INC. | PN-0005643 | 02323407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |