FDA Adverse Event
Death
Summary report: N
DIALOG+
MDR report key: 10137247
·
Received June 10, 2020
Report
- Report Number
- 2521402-2020-00004
- Event Type
- Death
- Date Received
- June 10, 2020
- Date of Event
- May 30, 2020
- Report Date
- November 3, 2020
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- KDI
- UDI-DI
- 04046963686345
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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: PATIENT COMPLAINED OF SHORTNESS OF BREATH (SOB) DURING TREATMENT AND WAS TAKEN OFF TREATMENT EARLY. PATIENT'S OXYGEN SATURATION LEVEL DROPPED BELOW 88%. ONCE THE BLOOD WAS RETURNED THE PATIENT CODED AND PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601225 | DIALOG+ | HIGH PERMEABILITY | KDI | B. BRAUN AVITUM AG - MELSUNGEN | 710200L | 04046963686345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O |