FDA Adverse Event
Other
Summary report: N
ALARIS SYSTEM PUMP MODULE
MDR report key: 1053569
·
Received May 28, 2008
Report
- Report Number
- 2016493-2008-00051
- Event Type
- Other
- Date Received
- May 28, 2008
- Date of Event
- April 16, 2008
- Report Date
- April 29, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FRN
- PMA / PMN Number
- K950419
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 05/28/2008. REVIEW OF LOGS WHICH WERE SENT BY CUSTOMER DID NOT INCLUDE DATA FROM THE DATE OF THE REPORTED EVENT. THE INFUSION PUMP HAS BEEN REQUESTED. THE INVESTIGATION IS ON-GOING. F/U REPORT WILL BE FILED IF ADD'L INFO IS OBTAINED AND/OR THE PUMP IS RECEIVED FOR INVESTIGATION. PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. THIS REPORT WAS FILED BY THE MFR.
Description of Event or Problem · 1
THE INITIAL REPORT STATED THAT A MAGNESIUM INFUSION OF 2GMS IN 50 MLS OF NORMAL SALINE WAS TO INFUSE OVER 2 HRS AND INSTEAD INFUSED IN 30 MINUTES. NO PT HARM OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SYSTEM PUMP MODULE | PRN, INFUSION PUMP | FRN | CARDINAL HEALTH ALARIS PRODUCTS | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |