MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-22 for INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 866148 manufactured by Philips Medical Systems.
[97861061]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[97861062]
The customer noticed that in the configuration editor there were two orders having the same order labels but they were two different orders with different formulations. A severely ill patient received an under-dose of an antimicrobial recently due to the clinicians' selection of the duplicate/incorrect standard order; this presented a potential for septicemia.
Patient Sequence No: 1, Text Type: D, B5
[110749252]
The issue is due to a configuration error. The configuration of the standard orders is restricted to a special patient type. For a standard order of ambisome there was a duplicate that did not have patient type "exclusion" configured. The customer noticed that in the configuration editor there were two orders of ambisome, one with patient type exclusion and one without patient type exclusion, both existed in the configuration dated (b)(6)2017. The stored time of both rows are (b)(6)2010 and (b)(6)2010. That indicated these data was there since 2010. This resulted in both orders having the same order labels but having different formulations. A severely ill patient received an under dose of the antimicrobial, ambisome, due to the clinicians' selection of the duplicate/incorrect standard order thus presenting a potential for septicemia. The root cause of the redundant standard orders is unknown due to the bad data in the configuration editor that was there since feb 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-00670 |
| MDR Report Key | 7209029 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-15 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2018-01-22 |
| 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. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 |
| Generic Name | CLINICAL INFORMATION MANAGEMENT SYSTEM |
| Product Code | DXJ |
| Date Received | 2018-01-22 |
| Model Number | 866148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-22 |