FDA Adverse Event
Malfunction
Summary report: N
PRISMA CONTROL UNIT
MDR report key: 758453
·
Received October 21, 2005
Report
- Report Number
- 9616240-2005-00028
- Event Type
- Malfunction
- Date Received
- October 21, 2005
- Report Date
- September 23, 2005
- Manufacturer
- GAMBRO DASCO
- Product Code
- KDI
- Removal / Correction Number
- 9616240-9/7-05-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INJURY WAS REPORTED. NO MACHINE'S MALFUNCTION WAS IDENTIFIED BY GAMBRO TECHNICAL SERVICES (GTS) FIELD REPRESENTATIVES. HE COMPLETED A MOCK TREATMENT: THE MACHINE WAS IN SPECIFICATION. AS CORRECTIVE ACTION, ON AUGUST 16, 2005, A SAFETY ALERT WAS RELEASED. THE FIELD CORRECTION 9616240-9/7/05-001-C WAS INITIATED ON AUGUST 25TH, 2005.
Description of Event or Problem · 1
CUSTOMER REPORTED: "....FLUID REMOVAL INCORRECT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMA CONTROL UNIT | INTENSIVE CARE HEMODIALYSIS | KDI | GAMBRO DASCO | PRISMA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |