FDA Adverse Event
Malfunction
Summary report: N
599 SPACE SAVER
MDR report key: 205770
·
Received January 6, 1999
Report
- Report Number
- 2016493-1998-00240
- Event Type
- Malfunction
- Date Received
- January 6, 1999
- Date of Event
- December 8, 1998
- Manufacturer
- ALARIS MEDICAL SYSTEMS, INC.
- Product Code
- FRN
- Removal / Correction Number
- Z302-8
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT ON DOPAMINE WHEN ALLEGED OVERINFUSION OCCURRED. PT'S BLOOD PRESSURE ELEVATED TO 220/150; INFUSION STOPPED AND DEVICE REMOVED. EVENT TOOK PLACE WHILE NURSE WAS CHANGING FLUIDS BAG. NO PT COMPROMISE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 599 SPACE SAVER | INFUSION PUMP | FRN | ALARIS MEDICAL SYSTEMS, INC. | 599 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |