MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-30 for ACUDOSE ALND2 manufactured by Aesynt Incorporated.
[4563621]
Physician reported that he had a discrepancy caused by a fatal error that triggered a full re-boot of acudose while a caesarian section (c-section) was underway. He said he had pulled fentanyl and hydromorphine when it started to shut down at the end of dispensing the hydromorphine. This caused a discrepancy that was resolved. The complete re-boot process took about 4 minutes. There was no harm to the patient or infant. Aesynt reported that they will be sending a service technician to replace pockets on the narcotic drawer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3876192 |
| MDR Report Key | 3876192 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-29 |
| Report Date | 2014-05-30 |
| Date Reported to FDA | 2014-05-30 |
| Date Reported to Mfgr | 2014-06-17 |
| Date Added to Maude | 2014-06-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUDOSE |
| Generic Name | CABINET, TABLE AND TRAY, ANESTHESIA |
| Product Code | BRY |
| Date Received | 2014-05-30 |
| Model Number | ALND2 |
| Catalog Number | ALND2 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESYNT INCORPORATED |
| Manufacturer Address | 500 CRANBERRY WOODS DR. SUITE 400 CRANBERRY TOWNSHIP PA 16066 US 16066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |