N
Patient 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
MAUDE MDR 6029656
- MDR report key
- 6029656
- Report number
- 1218950-2016-06473
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-06
- Date received
- 2016-10-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. BETTY HARRIS
- Address
- 3000 MINUTEMAN ROAD ANDOVER MA 01810 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTELLISPACE CC & ANESTHESIA | INTELLISPACE CC & ANESTHESIA | PHILIPS MEDICAL SYSTEMS | DXJ | 866072 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-14 | 0 | 1. D; 2. L; 3. O |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED A PATIENT DEATH OCCURRED DUE TO THE ADMINISTRATION TIME OF A DRUG NOT APPEARING IN THE ICCA WORKLIST . THE PATIENT WAS DESCRIBED TO HAVE BEEN IN SEPTIC SHOCK AND EXPIRED.
N
Patient 1
NO MALFUNCTION OF THE DEVICE WAS DETECTED. THIS WAS A CLINICAL WORKFLOW ERROR. THERE WAS NO FREQUENCY ENTERED FOR THE ORDER BY THE CLINICAL STAFF. IN ADDITION, THE CLINICAL STAFF FAILED TO NOTICE AN ICON (CLOCK ICON WITH A QUESTION MARK ) THAT INDICATES THAT THE ORDER IS MISSING A SCHEDULE AND NEEDS TO BE COMPLETED. THE NURSE WAS ONLY USING THE WORKLIST. ICCA HAS A RED WARNING MESSAGE THAT STATES NOT TO USE THE WORKLIST EXCLUSIVELY. THE ADMINISTRATION RECORD SHOULD ALWAYS BE USED. THE SCHEDULE WASN?T CREATED FOR AN ANTIFUNGAL DRUG ORDER BECAUSE THERE WASN?T A FREQUENCY ENTERED BY THE CLINICAL STAFF. A SCHEDULE CANNOT BE CREATED WITHOUT A FREQUENCY ENTERED. A PHILIPS CLINICAL SPECIALIST EXPLAINED THE CORRECT WORKFLOW TO THE END USER AND ALSO COMMUNICATED TO NOT RELY EXPLICITLY ON THE WORK LIST AND RECOMMENDED TO ALWAYS CHECK IN THE MAR FOR COMPLETED ORDERS AS DOCUMENTED IN THE CLINICIANS TOOLKIT MANUAL. THE DEVICE REMAINS AT THE CUSTOMER SITE, AND THERE HAVE BEEN NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE.