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 2000-09-14 for PERCUPUMP CT INJECTOR W/EDA 8805 manufactured by E-z-em, Inc..
[182486]
Unit was set to inject a total volume of 100 ml of contrast at a flow rate of 2. 5 cc/sec. According to facility, the system failed to detect an extravasation, estimated to be approx 90 cc's.
Patient Sequence No: 1, Text Type: D, B5
[198964]
System missed an extravasation of 90 cc's that the edca patch did not pick up. System began to read "eda inoperable. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2000-00028 |
| MDR Report Key | 296720 |
| Report Source | 05,06,07 |
| Date Received | 2000-09-14 |
| Date of Report | 2000-08-22 |
| Date of Event | 2000-08-22 |
| Date Facility Aware | 2000-08-22 |
| Report Date | 2000-08-22 |
| Date Reported to Mfgr | 2000-08-22 |
| Date Mfgr Received | 2000-08-22 |
| Device Manufacturer Date | 2000-04-01 |
| Date Added to Maude | 2000-09-21 |
| 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 | 3 |
| Manufacturer Contact | PETER APRILE, R.PH. |
| Manufacturer Street | 717 MAIN ST |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP CT INJECTOR W/EDA |
| Generic Name | CT INJECTOR WITH EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2000-09-14 |
| Model Number | NA |
| Catalog Number | 8805 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 287218 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 113-117 MAGNOLIA AVE. WESTBURY NY 11590 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 | 2000-09-14 |