MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for CERNER AUTOMATED ALIQUOTTER AA N/A manufactured by Cerner Corporation.
[54295062]
Cerner has made changes to the barcode reader to narrow the scanner beam and realign the scanner to the proper angle. Cerner is implementing a further hardware modification to disallow the barcode reader to be out of alignment. Cerner is in contact with the client regarding the resolution of the issue and provided formal notification of the issue on august 18, 2016. The other client with the same version of the device was notified of the issue on august 18, 2016. Cerner corporation will provide a follow-up report when the modification is fully implemented.
Patient Sequence No: 1, Text Type: N, H10
[54295063]
This report documents information related to an issue reported in association with functionality included in cerner automated aliquotter. The issue involves functionality of the cerner automated aliquotter. The issue occurs when a primary specimen moves into the secondary lane in the aliquotter and the automated aliquotter barcode scanner is misaligned. When this occurs, the barcode reader reads the incorrect tube and not the tube the system was attempting to aliquot into. This could lead to a specimen being aliquoted into a tube that contains the specimen from a different patient. Cerner has received a report of one occurrence of this issue but there was no patient care incident as the specimens were removed from the line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2016-00012 |
| MDR Report Key | 5915946 |
| Date Received | 2016-08-30 |
| Date of Report | 2017-08-28 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2016-08-30 |
| 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 Contact | MS. SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CERNER AUTOMATED ALIQUOTTER |
| Generic Name | SOFTWARE |
| Product Code | JQW |
| Date Received | 2016-08-30 |
| Model Number | AA |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-30 |