MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-03-06 for IMED GEMINI PC1 1310 NA manufactured by Imed Corp..
[18953175]
Overinfusion. Hosp reported the pump rate set at 100ml/hr and 1000 mls were delivered in two hrs. There were no long lasting effects to the pt. Hosp biomedical engineering tested the pump and found no problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021283-1997-00007 |
| MDR Report Key | 76060 |
| Report Source | 05,06 |
| Date Received | 1997-03-06 |
| Date Mfgr Received | 1997-02-04 |
| Device Manufacturer Date | 1992-12-01 |
| Date Added to Maude | 1997-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMED GEMINI PC1 |
| Generic Name | VOLUMETRIC INFUSION PUMP/CONTROLLER |
| Product Code | LDR |
| Date Received | 1997-03-06 |
| Returned To Mfg | 1997-02-04 |
| Model Number | 1310 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 75809 |
| Manufacturer | IMED CORP. |
| Manufacturer Address | 9775 BUSINESSPARK AVE. SAN DIEGO CA 92131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-06 |