MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-17 for AC PUMP POWER CORD CSA GREY 400100678 manufactured by Baxter Healthcare Corportation.
[183655298]
The device was not returned and the serial 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
[183655299]
It was reported that the power cord (main module) of an exactamix automated compounding device was observed frayed. It was further reported the "main power cord had exposed wires. This issue was noted during programming/setup. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01462 |
| MDR Report Key | 9838924 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-17 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | ECM - 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 | 2020-03-17 |
| Model Number | NA |
| Catalog Number | 400100678 |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORTATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |