FDA Adverse Event
Death
Summary report: N
BICART 720G USA
MDR report key: 1051530
·
Received May 21, 2008
Report
- Report Number
- 9616023-2008-00001
- Event Type
- Death
- Date Received
- May 21, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 21, 2008
- Manufacturer
- GAMBRO LUNDIA AB
- Product Code
- KPO
- PMA / PMN Number
- K013724
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CLINICAL INVESTIGATION PROCESS IS STILL ONGOING. THE INFO AVAILABLE DOES NOT SUGGEST A GAMBRO PRODUCT HAS CAUSED OR CONTRIBUTED TO THE EVENT. IT IS A GAMBRO POLICY TO REPORT ALL DEATHS OCCURRING DURING OR WITHIN 24 HOURS OF TREATMENT. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.
Description of Event or Problem · 1
IN 2008, A HEALTHCARE PROFESSIONAL REPORTED TO GAMBRO THAT WITHIN FIVE MINUTES OF INITIATING TREATMENT A PT DEVELOPED CHEST TIGHTNESS, ALONG WITH FACIAL AND TONGUE EDEMA. THE PT WAS ADMINISTERED CORTICOSTEROIDS AND ADRENALIN. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BICART 720G USA | NONE | KPO | GAMBRO LUNDIA AB | 103353 | 85117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |