FDA Adverse Event
Other
Summary report: N
ALARIS SYSTEM PUMP MODULE
MDR report key: 1082242
·
Received July 23, 2008
Report
- Report Number
- 2016493-2008-00085
- Event Type
- Other
- Date Received
- July 23, 2008
- Date of Event
- May 21, 2008
- Report Date
- June 27, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FRN
- PMA / PMN Number
- K012383
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
FACILITY BIOMED REPORTED NURSE PROGRAMMED INFUSION OF D51/2NS AT 40 ML/HR. PUMP WAS LATER MAKING NOISY SOUNDS AND WHEN USER CHECKED IT NOTED RATE WAS SET AT 440 ML/HR. SHE CHANGED RATE BACK TO 40 ML/HR. PT WAS STABLE WITH LUNGS CLEAR, NO SHORTNESS OF BREATH, AND VITAL SIGNS STABLE. INVESTIGATION IS ONGOING. FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SYSTEM PUMP MODULE | FRN, INFUSION PUMP | FRN | CARDINAL HEALTH ALARIS PRODUCTS | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other | ASSOCIATED PSU |