MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-11-19 for STAT 2 PUMPETTE IV CONTROLLER PS2V-20 manufactured by Conmed Corp..
[17828000]
"during an open-heart coronary artery bypass procedure the device continued to "drip" intravenous solution despite the gravity flow dial controller being placed in the "off" position. No permanent injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2004-00076 |
| MDR Report Key | 555785 |
| Report Source | 05,06 |
| Date Received | 2004-11-19 |
| Date of Report | 2004-10-21 |
| Date of Event | 2004-10-21 |
| Date Mfgr Received | 2004-10-21 |
| Date Added to Maude | 2004-11-22 |
| 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 | 3 |
| 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 PUMPETTE IV CONTROLLER |
| Generic Name | PUMPETTE IV CONTROLLER |
| Product Code | LDR |
| Date Received | 2004-11-19 |
| Returned To Mfg | 2004-11-12 |
| Model Number | NA |
| Catalog Number | PS2V-20 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 545431 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST. UTICA NY 135011203 US |
| Baseline Brand Name | STAT 2 PUMPETTE IV CONTROLLER |
| Baseline Generic Name | PUMPETTE IV CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | PS2V-20 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-19 |