FDA Adverse Event
Malfunction
Summary report: N
PRISMAFLEX SYSTEM
MDR report key: 726099
·
Received June 8, 2006
Report
- Report Number
- 9616026-2006-00226
- Event Type
- Malfunction
- Date Received
- June 8, 2006
- Date of Event
- May 1, 2006
- Report Date
- May 9, 2006
- Manufacturer
- GAMBRO LUNDIA AB, MONITOR DIVISION
- Product Code
- MQS
- PMA / PMN Number
- k041005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A GAMBRO TECHNICIAN EVALUATED THE MACHINE BUT COULD NOT LOCALIZED THE PROBLEM. NO PT INJURY NOR MEDICAL INTERVENTION WAS REPORTED. FURTHER INVESTIGATION IS BEING CONDUCTED BY THE MANUFACTURER. THE COMPANY IS AWARE OF THIS MACHINE MALFUNCTION (GENERAL SYSTEM FAILURE) AND IS WORKING ON CORRECTIONS. 510(K)# IS K041005.
Description of Event or Problem · 1
CUSTOMER REPORTED A SECOND INCIDENT WITH HIGH PRESSURE PROBLEMS AND MACHINE 'GENERAL SYSTEM FAILURE' ERROR CODES DURING TREATMENT. BLOOD LOSS VOLUME UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMAFLEX SYSTEM | INTENSVIE CARE HEMODIALYSIS | MQS | GAMBRO LUNDIA AB, MONITOR DIVISION | 107493 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |