MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for PICIS PERIOPERATIVE AND CRITICAL CARE 8.6 manufactured by Picis Clinical Solutions, Inc..
[61601986]
The reported issue has been determined to potentially affect picis perioperative and critical care versions 8. 6 service pack 4 and 8. 6 service pack 5 when both preop manager and or manager are utilized together. A software solution has been created and will be made available to potentially affected clients and included in a future 8. 6 service pack. Additionally, the issue is experienced when an unusual client workflow is followed. According to clinical representative feedback, it is not typical for clients to enter precautions into picis preop manager ahead of a booking being created in picis or manager. The company reviewed related user documentation and determined the user documentation may be enhanced with a cautionary statement to ensure customers are aware of the need to create a booking in picis or manager prior to the precautions being entered in picis preop manager. User documentation will be enhanced with the release of a future 8. 6 service pack.
Patient Sequence No: 1, Text Type: N, H10
[61601989]
Picis clinical solutions, inc. (picis) has received and investigated a customer report of an interoperability issue within the picis perioperative and critical care software application. Customer reported that a precaution entered into preop manager did not flow to the or manager application as expected. The investigation into the reported incident concluded that the root cause resulted in the software not capturing the precaution in or manager that was entered into preop manager. The investigation has identified an issue where the picis intermessaging service (pims) channels create excessive threads and adversely impact the picis connectivity manager (pcm). As a result, messages may not be processed as expected (the message that links the preadmission patient and the patient from the booking may not be processed). Our findings revealed the unique situation reported by the complainant occurs when clients follow a particular workflow. After internal investigation with clinical resources, it was determined that the workflow utilized by this reporting client was not common. Reporting of this condition from clients is rare (only one reported client complaint to date after more than ten years on the market), as the issue is only experienced with unique conditions and workflows. A software solution has been designed to address this issue. The user documentation will be enhanced to include a cautionary statement regarding the proper data workflow. Event description customer report: "this patient had a slate alert (osam) entered in pom (picis preop manager) by the pss rn yesterday (b)(6) 2016 but did not appear on the slate today (b)(6) 2016 as seen below. The nurse has now entered the alert in orm (picis or manager) and this carried over to the slate. We need to ensure this does not happen for safety reasons as we were under the understanding that we are to enter slate alerts in pom (picis preop manager) and these will carry forward to the slate. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005244943-2016-00001 |
| MDR Report Key | 6139589 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-07 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-12-01 |
| 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. KERRY ARMSTRONG |
| Manufacturer Street | 100 QUANNAPOWITT PARKWAY SUITE 405 |
| Manufacturer City | WAKEFIELD MA 01880 |
| Manufacturer Country | US |
| Manufacturer Postal | 01880 |
| Manufacturer Phone | 7815573000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PICIS PERIOPERATIVE AND CRITICAL CARE |
| Generic Name | SOFTWARE, TRANSMISSION & STORAGE |
| Product Code | NSX |
| Date Received | 2016-12-01 |
| Model Number | 8.6 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PICIS CLINICAL SOLUTIONS, INC. |
| Manufacturer Address | 100 QUANNAPOWITT PARKWAY SUITE 405 WAKEFIELD MA 01880 US 01880 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-01 |