FDA Adverse Event
Injury
Summary report: N
3300 PCA SYRINGE PUMP
MDR report key: 512512
·
Received February 19, 2004
Report
- Report Number
- 9612511-2004-00007
- Event Type
- Injury
- Date Received
- February 19, 2004
- Report Date
- February 16, 2004
- Manufacturer
- GRASEBY MEDICAL LTD.
- Product Code
- MEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PT [INPATIENT] HAD DRAWN 2 X 7ML OPIATE FROM A RUNNING PUMP. A RESCUE SERVICE PROFESSIONAL. THEY USED A 3-WAY STOPCOCK AND A LINE [Y-SYSTEM] FROM BRAUN. THEN INJECTED THE OPIATE INTO A VEIN. THEY STOPPED BREATHING AND HAD TO BE RESUSCITATED IN THE INTENSIVE CARE UNIT. THERE WAS NO PERMANENT INJURY. NURSING STAFF HAD NOT REACTED ADEQUATELY TO THE PUMP ALARMS. THEY HAD NOT NOTICED THE RESETTING OF THE SYSTEM. INITIAL CONCLUSION = PT TAMPERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3300 PCA SYRINGE PUMP | SYRINGE PUMP | MEA | GRASEBY MEDICAL LTD. | 3300 PCA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |