MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-12-01 for MEDFUSION 2001I SYRINGE INFUSION PUMP 2010I manufactured by Smiths Medical Md, Inc..
[553219]
It was reported by the bio-med tech at the user facility that the device "overinfused. " add'l info was requested and rec'd from the user facility's risk manager who reported that there was no harm to the pt and that "the medication was given at a faster rate than the pump indicates should have been given. " additionally they did perform a short test with water in the syringe and it appeared to be working, but did not perform any long term testing.
Patient Sequence No: 1, Text Type: D, B5
[7915516]
The suspect device was returned and evaluated. An attempt was made to operate the pump to test the delivery accuracy, this was not possible due to numerous issues with the device. The tamper sticker was not intact, the device had been serviced in the field and there were multple indications that the pump was not reasssembled correctly. Additionally, there was physical damage and fluid ingression and the device was out of calibration. The device was evaluated and the alleged failure could not be duplicated as the device was rec'd in an inoperable condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2006-00175 |
| MDR Report Key | 793742 |
| Report Source | 06 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-11-30 |
| Date of Event | 2006-10-28 |
| Date Facility Aware | 2006-10-28 |
| Report Date | 2006-11-30 |
| Date Reported to FDA | 2006-11-30 |
| Date Mfgr Received | 2006-11-01 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2006-12-14 |
| 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 | 2006-12-01 |
| Returned To Mfg | 2006-11-10 |
| Model Number | 2010I |
| Catalog Number | 2010I |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 781359 |
| Manufacturer | SMITHS MEDICAL MD, INC. |
| Manufacturer Address | * ST. PAUL MN * US |
| Baseline Brand Name | MEDFUSION 2010I SYRINGE INFUSION PUMP |
| Baseline Generic Name | SYRINGE INFUSION PUMP |
| Baseline Model No | 2010I |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-01 |