MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-11 for ED PULSECHECK 5.4 manufactured by Picis Clinical Solutions, Inc..
[33963145]
After investigation picis clinical solutions has confirmed the reported defect and will be providing a solution ina future ed pulse check software solution. A capa has been initiated to further analyze the root cause(s) of this defect and to implement corrective action as necessary. No adverse events have been attributed to this issue. Clinical review suggests there is a potential for ordering and administering a medication that could interact with a patient's current medications without a notification being provided due to the omission from their current medication list. The nature and extent of any untoward outcome would be directly related to the severity of the interaction between the medication ordered and the home medication that is omitted. The root cause for clinicians being unable to apply a medication to a patient visit has been identified and a software solution is being developed for this specific client, with plans to distribute to the ed pulse check client base as part of a future service pack as a preventive measure to remove risk on similar interfaces that might be deployed at other client sites in the future.
Patient Sequence No: 1, Text Type: N, H10
[33963146]
Picis clinical solutions received a customer complaint on (b)(6) 2015: when a current medication is sent on the inbound adt via a08, and the user clicks 'n/a' initially, that medication is not able to be re-added either through the "search" or quicklist to the current visit. During the initial patient triage interview the nurse marks a specific medication that has come in from previous/external via adt as 'na'. So aspirin 81 mg po, for example, is marked n/a because the patient claims they are not taking that anymore. Sometime later in the visit, the pharmacist is reviewing the record and determines that aspirin should in fact be active as a current medication. That specific medication is not able to be added back to the current meds visit. It allows you to select it, but when you find and submit, the screen refreshes and nothing gets entered. The clinician is able to enter the medication as free text, however since the medication is not entered as structured, the ed pulse check application will not perform medication allergy interaction checking. It was determined that this issue is likely contained to one existing client on ed pulse check v5. 4 due to their interface design and configuration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005244943-2015-00005 |
| MDR Report Key | 5290728 |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-18 |
| Date Mfgr Received | 2015-11-18 |
| Date Added to Maude | 2015-12-11 |
| 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 |
| Manufacturer G1 | PICIS CLINICAL SOLUTIONS, INC. |
| Manufacturer Street | 100 QUANNAPOWITT PARKWAY SUITE 405 |
| Manufacturer City | WAKEFIELD MA 01880 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01880 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ED PULSECHECK |
| Generic Name | SOFTWARE, TRANSMISSION AND STORAGE |
| Product Code | NSX |
| Date Received | 2015-12-11 |
| Model Number | 5.4 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-12-11 |