MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-06 for MEDFUSION 2001I SYRINGE INFUSION PUMP 2010I NA manufactured by Smiths Medical Md.
[661619]
The reporter stated that the unit displays wrong syringe size and could not be calibrated. There was no pt injury or treatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[7963941]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2006-00114 |
| MDR Report Key | 862499 |
| Report Source | 06 |
| Date Received | 2006-10-06 |
| Date of Report | 2006-10-06 |
| Date of Event | 2006-09-07 |
| Date Facility Aware | 2006-09-07 |
| Report Date | 2006-10-06 |
| Date Reported to FDA | 2006-10-06 |
| Date Mfgr Received | 2006-09-07 |
| Device Manufacturer Date | 1995-03-01 |
| Date Added to Maude | 2007-06-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDFUSION 2001I SYRINGE INFUSION PUMP |
| Generic Name | SYRINGE INFUSION PUMP |
| Product Code | FIH |
| Date Received | 2006-10-06 |
| Model Number | 2010I |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 845509 |
| Manufacturer | SMITHS MEDICAL MD |
| Manufacturer Address | * ST. PAUL MN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-06 |