FDA Adverse Event
Death
Summary report: N
A-15
MDR report key: 358819
·
Received October 23, 2001
Report
- Report Number
- 1423500-2001-01501
- Event Type
- Death
- Date Received
- October 23, 2001
- Date of Event
- October 12, 2001
- Report Date
- October 13, 2001
- Manufacturer
- ALTHIN MEDICAL, AN AFFILIATE OF BHC
- Product Code
- FJI
- Removal / Correction Number
- 1423500-10/16/01-002R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BAXTER AFFILIATE REPORTS ONE INCIDENT OF A PATIENT DEATH WHICH OCCURRED AFTER AN UNEVENTFUL DIALYSIS TREATMENT. PT COMPLAINED OF SUFFOCATION IN THE CHEST, WENT TO LAY DOWN AND THEN LOST CONSCIOUSNESS. PT WAS INTUBATED AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL. NO FURTHER INFO AVAILABLE.
Description of Event or Problem · 1
BAXTER AFFILIATE REPORTS ONE INCIDENT OF A PATIENT DEATH. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47799 | A-15 | HOLLOW FIBER DIALYZER | FJI | ALTHIN MEDICAL, AN AFFILIATE OF BHC | A-15 | 2001F07P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death | CONCENTRATE (MANUFACTURED BY PLIVA).| HEMODIALYSIS SOLUTION-PLIVA HKDM11. |