MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-16 for AC PUMP POWER CORD CSA GREY 400100678 manufactured by Baxter Healthcare Corporation.
[175221493]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[175221494]
It was reported an automated compounding device (acd) hardware power cord had exposed wires. This was identified during an unspecified process step prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[179669096]
The device was not returned and the lot number is unknown: therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07584 |
| MDR Report Key | 9596075 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-16 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-01-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - ENGLEWOOD |
| Manufacturer Street | 14445 GRASSLANDS DR |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AC PUMP POWER CORD CSA GREY |
| Generic Name | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
| Product Code | NEP |
| Date Received | 2020-01-16 |
| Model Number | NA |
| Catalog Number | 400100678 |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |