FDA Adverse Event
Other
Summary report: N
PRISMAFLEX
MDR report key: 2136550
·
Received September 21, 2007
Report
- Report Number
- 9616026-2007-00098
- Event Type
- Other
- Date Received
- September 21, 2007
- Date of Event
- August 21, 2007
- Report Date
- August 22, 2007
- Manufacturer
- GAMBRO LUNDIA AB
- Product Code
- KDI
- PMA / PMN Number
- K041005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED INCIDENT HAS BEEN CLASSIFIED AS A FLOW RATE DISCREPANCY. THE TREATMENT FILES ARE NOT AVAILABLE. THE ACTUAL FLOW RATE DISCREPANCY WAS 20 ML/MIN, THE PT WAS ASYMPTOMATIC AND NO MEDICAL INTERVENTION REQUIRED. GAMBRO LUNDIA AB HAS DEVELOPED A PROCEDURE FOR FLOW RATE DISCREPANCY, AS DESCRIBED IN THE ADVISORY NOTICE 019 DATED (B)(4) 2007, SOFTWARE CHANGES HAVE ALSO BEEN MADE, WHEN WILL BE IMPLEMENTED IN FUTURE REVISION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SET BLOOD FLOW RATE IS NOT THE SAME AS ON THE STATUS SCREEN. NO PT INJURY OR CLINICAL CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMAFLEX | INTENSIVE CARE HEMODIALYSIS | KDI | GAMBRO LUNDIA AB | 107493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |