MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-30 for STAT 2 PUMPETTE manufactured by Conmed Corp..
[27850509]
Pt received in emergency department by ems and lidocaine drip infusing with stat 2 pumpette tubing with built in calibrate set at 30ml/hr. Set delivered 250cc bag over 2 hrs with this tubing. Pt developed stroke like symptoms and required icu admit for lidocaine toxicity. Mfr # 1317214-2004-00025.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5131268 |
| MDR Report Key | 5131268 |
| Date Received | 2004-04-30 |
| Date of Report | 2004-03-15 |
| Date of Event | 2004-02-29 |
| Date Facility Aware | 2004-03-15 |
| Report Date | 2004-03-15 |
| Date Reported to Mfgr | 2004-03-30 |
| Date Added to Maude | 2015-10-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAT 2 PUMPETTE |
| Generic Name | PRIMARY ADMINISTRATION SET |
| Product Code | LDR |
| Date Received | 2004-04-30 |
| Lot Number | 16925 |
| Device Expiration Date | 2008-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2004-04-30 |