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 2020-03-16 for EM 2400, LOAD CELL MODULE 2400L manufactured by Baxter Healthcare Corportation.
[183502892]
The device was received for evaluation. During visual examination, the cord is frayed with exposed wires with several internal conductors cut and exposed. The reported condition was verified. Due to the nature of the returned sample, no further testing could be performed. The cause of the condition could not be determined. To resolve the condition, the scale cable assembly will be replaced. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183502893]
It was reported that the cord (load cell module) of an exacta mix automated compounding device were damaged. It was further reported that the load cell wires were frayed and exposed. 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 | 1416980-2020-01414 |
| MDR Report Key | 9834871 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| 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 | PHARMACIST |
| 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 | EM 2400, LOAD CELL MODULE |
| Generic Name | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
| Product Code | NEP |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-02-21 |
| Model Number | NA |
| Catalog Number | 2400L |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORTATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |