FDA Adverse Event
Death
Summary report: N
DIALOG+
MDR report key: 10454476
·
Received August 26, 2020
Report
- Report Number
- 2521402-2020-00005
- Event Type
- Death
- Date Received
- August 26, 2020
- Date of Event
- August 19, 2020
- Report Date
- November 3, 2020
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- KDI
- UDI-DI
- 04046964285608
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 0
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT#: (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED FOR CORRECTIONS. SECTION B2 HAS BEEN CHANGED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
AS REPORTED BY USER FACILITY: BIO-MED REPORTED A PATIENT CODED AND PASSED AWAY DURING A TREATMENT. BIO-MED VERIFIED ALL THE MACHINE SAFETY CALIBRATIONS AND AT THE TIME OF THE INCIDENT THE DIALOG MACHINE WAS OPERATING WITHIN SPECIFIED LIMITS AND TOLERANCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 920948 | DIALOG+ | HIGH PERMEABILITY | KDI | B. BRAUN AVITUM AG - MELSUNGEN | 710200S | 04046964285608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O |