FDA Adverse Event
Injury
Summary report: N
IMED GEMINI INFUSION PUMP
MDR report key: 1358378
·
Received April 6, 2009
Report
- Report Number
- MW5010660
- Event Type
- Injury
- Date Received
- April 6, 2009
- Date of Event
- March 18, 2009
- Report Date
- April 6, 2009
- Manufacturer
- CARDINAL HELATH, ALARIS PRODUCTS
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT WAS STARTED ON A HEPARIN DRIP AT 8.1 CC/H (810 UNITS/HR) AT 0200. AT 0745, THE 250 CC BAG WAS FOUND EMPTY. PUMP WAS PROGRAMMED CORRECTLY AND VERIFIED BY A SECOND STAFF MEMBER BEFORE STARTING THE DRIP. AT A RATE OF 8.1 CC/H, THE BAG SHOULD HAVE LASTED OVER 30 HOURS. THE PUMP WAS TAKEN OUT OF SERVICE AND SENT TO BIOMEDICAL SERVICES TO BE CHECKED. BIOMED TESTED PUMP AND CONFIRMED IN 2009 THAT PUMP MALFUNCTIONED. THIS PUMP WAS LEASED FROM A RENTAL COMPANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMED GEMINI INFUSION PUMP | IV PUMP | FRN | CARDINAL HELATH, ALARIS PRODUCTS | PC-2TX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |