FDA Adverse Event
Malfunction
Summary report: N
TABLO(R) HEMODIALYSIS SYSTEM
MDR report key: 14013726
·
Received April 5, 2022
Report
- Report Number
- 14013726
- Event Type
- Malfunction
- Date Received
- April 5, 2022
- Date of Event
- February 13, 2022
- Report Date
- March 9, 2022
- Manufacturer
- OUTSET MEDICAL, INC.
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
NO EQUIPMENT ISSUES OR HUMAN FACTORS INTERACTING WITH EQUIPMENT IDENTIFIED.
Description of Event or Problem · 0
TABLO HAD BEEN RESTARTED AS SCHEDULED FOLLOWING A HEAT CYCLE. ONE HOUR LATER RNS NOTED LEAKING FROM RED PORT OF TABLO DIALYZER, THE MACHINE DID NOT ALARM, CONNECTION WAS SLIGHTLY LOOSE, BUT WE WERE UNABLE TO RESTART THE MACHINE, SO THE CARTRIDGE AND DIALYZER WERE CHANGED. TABLO SHOULD ALARM WHEN THE SYSTEM IS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527501 | TABLO(R) HEMODIALYSIS SYSTEM | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | OUTSET MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24455 DA | Male | Other |