FDA Adverse Event
Injury
Summary report: N
CURLIN MEDICAL
MDR report key: 1327196
·
Received February 24, 2009
Report
- Report Number
- MW5010075
- Event Type
- Injury
- Date Received
- February 24, 2009
- Date of Event
- February 12, 2009
- Report Date
- February 24, 2009
- Manufacturer
- CURLIN MEDICAL, INC.
- Product Code
- MEA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A MORPHINE PCA PUMP WAS INITIATED AND STARTED POST-OPERATIVELY ON PT IN 2009, AT 1830 - 50 MG MORPHINE/50 CC NS. THE PUMP WAS SET TO ADMINISTER 1 MG PER 15 MINUTES. AFTER PRIMING THE PUMP AND TUBING 35 CC WERE LEFT IN BAG PRIOR TO INITIATION OF MEDICATION. RN CHECKED PT AND PUMP AT 1920, THE INFUSION BAG WAS EMPTY BUT THE PUMP READ THAT THERE WAS STILL 35 CC IN BAG AND 0 -ZERO- INFUSED. PT STABLE AND MONITORED CLOSELY. THE PUMP WAS TAKEN OUT OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN MEDICAL | 4000 CMS PUMP | MEA | CURLIN MEDICAL, INC. | 4000 CMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Life Threatening| S |