FDA Adverse Event
Other
Summary report: N
ALARIS INFUSION SYSTEM
MDR report key: 1242530
·
Received November 21, 2008
Report
- Report Number
- 2016493-2008-00192
- Event Type
- Other
- Date Received
- November 21, 2008
- Date of Event
- September 19, 2008
- Report Date
- October 28, 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
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTED UNDER INFUSION OF CARBOPLATIN. CARBOPLATIN WAS INFUSING WITH 595 ML TO RUN OVER 45 MINUTES. AT THE END OF 45 MINUTES, THERE WAS A RESIDUAL OF 95 ML AND AN ACTUAL RUN TIME WAS REPORTED AS 1 HOUR. NO PATIENT HARM. PRODUCT RETURN IS NOT EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS INFUSION SYSTEM | FRN, INFUSION SYSTEM | FRN | CARDINAL HEALTH ALARIS PRODUCTS | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |