FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 986023
·
Received August 27, 2007
Report
- Report Number
- 9616240-2007-00083
- Event Type
- Malfunction
- Date Received
- August 27, 2007
- Manufacturer
- GAMBRO DASCO S.P.A., MONITOR DIVISION
- Product Code
- KDI
- PMA / PMN Number
- K062090
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT OCCURRED DURING A PT TREATMENT. WHILE THE CATHETER WAS BEING FLUSHED AND THE LINES SWITCHED, THE FILTER CLOTTED. AS A RESULT, THE PT SUSTAINED AN APPROX BLOOD LOSS OF 65ML. SHE RESUMED CRRT TREATMENT ON ANOTHER PRISMA MACHINE (SN UNKNOWN) WITH NO FURTHER INCIDENTS. DURING THE CLOTTING EVENT AND THE SUBSEQUENT MALFUNCTION, THE PT DID NOT EXHIBIT ANY NEGATIVE SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED. SIMILARLY, NEITHER THE PT, NOR THE STAFF, SUSTAINED ANY INJURY OR REQUIRED ANY MEDICAL INTERVENTION RESULTING FROM THE REPORTED "BURNING" SMELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | KDI | GAMBRO DASCO S.P.A., MONITOR DIVISION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |