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 2006-04-13 for PERCUPUMP TOUCHSCREEN INJECTOR W/EDA 8805 manufactured by E-z-em, Inc..
[441277]
Customer reported that an extravasation occurred while injection iv contrast into a pt during a abdominal/pelvic ct exam. The eda patch was in use however the system did not alarm to stop the injection. Total amount of injection was 100ml non-ionic contrast at a flow rate of 2. 5ml/sec into the pt's wrist. Facility estimates the entire injection amount (100ml) extravasated. Pt did experience some swelling at the injection site, however no treatment was indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2006-00001 |
| MDR Report Key | 701044 |
| Report Source | 05,06,07 |
| Date Received | 2006-04-13 |
| Date of Report | 2006-03-17 |
| Date of Event | 2006-03-14 |
| Date Facility Aware | 2006-03-14 |
| Report Date | 2006-03-17 |
| Date Reported to Mfgr | 2006-03-17 |
| Date Mfgr Received | 2006-03-17 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2006-04-20 |
| 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 | GINA VOGELSBERG |
| Manufacturer Street | 1111 MARCUS AVE |
| Manufacturer City | LAKE SUCCESS NY 11042 |
| Manufacturer Country | US |
| Manufacturer Postal | 11042 |
| Manufacturer Phone | 5163338230 |
| Manufacturer G1 | E-Z-EM, INC |
| Manufacturer Street | 750 SUMMA AVE |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
| Generic Name | CT INJECTOR SYSTEM |
| Product Code | FIH |
| Date Received | 2006-04-13 |
| Model Number | NA |
| Catalog Number | 8805 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 690138 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | * WESTBURY NY * US |
| Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
| Baseline Generic Name | CT INJECTOR SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 8805 |
| Baseline ID | NA |
| Baseline Device Family | PERCUPUMP INJECTOR SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961845 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-13 |