FDA Adverse Event
Other
Summary report: N
3000 INFUSION PUMP
MDR report key: 514414
·
Received March 2, 2004
Report
- Report Number
- 9612511-2004-00008
- Event Type
- Other
- Date Received
- March 2, 2004
- Date of Event
- November 13, 2003
- Report Date
- March 2, 2004
- Manufacturer
- GRASEBY MEDICAL LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
VOUMETRIC PUMP AND 10 UNUSED SETS (PART NO: 591.082G LOT 115574.010/4) RETURNED FOR INVESTIGATION. USER NOTICED AIR IN LINE BELOW PUMP WHILST INFUSING A BLOOD TRANSFUSION. NO PT INJURY. REPORT READS THAT NUMEROUS AIR EMBOLUS NOTED IN TUBING ON VARIOUS OCCASIONS. IMMEDIATE ACTION TAKEN BY NURSING STAFF WAS TO STOP INFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3000 INFUSION PUMP | INFUSION PUMP | FRN | GRASEBY MEDICAL LTD. | 3000 (GRASEBY 500) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | 591-082 200 MICRON FILTER BLOOD SET 8C-591,| (INJECTION PORT SITE). |