MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-05-20 for STAT 2 IV CONTROLLER P-S2V-20N manufactured by Conmed Corp..
[17433288]
It was reported that "the nurse set the dial at 50ml without confirming the drip rate. When nurse returned the drip rate was at 70-80ml. The pt got too much fluid and went into congestive heart failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2003-00030 |
| MDR Report Key | 460996 |
| Report Source | 05,06,07 |
| Date Received | 2003-05-20 |
| Date of Report | 2003-04-21 |
| Date of Event | 2003-04-18 |
| Date Mfgr Received | 2003-04-21 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2003-05-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHARON RUSZALA |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243076 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAT 2 IV CONTROLLER |
| Generic Name | IV CONTROLLER |
| Product Code | LDR |
| Date Received | 2003-05-20 |
| Model Number | NA |
| Catalog Number | P-S2V-20N |
| Lot Number | 0212051 |
| ID Number | NA |
| Device Expiration Date | 2007-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 449938 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST. UTICA NY 135011203 US |
| Baseline Brand Name | STAT 2 IV CONTROLLER |
| Baseline Generic Name | IV CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | P-S2V-20N |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-05-20 |