ASAP MODULE OF EMR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-17 for ASAP MODULE OF EMR manufactured by Epic.

Event Text Entries

[23710554] Patient with multiple myeloma on chemotherapy. At routine clinic visit noted to be weak and sweaty, so transferred to er for eval and treatment. In er found to be hypotensive, tachycardic, confused, febrile, presumably due to sepsis / septic shock. During resuscitation, unable to enter orders for fluids, medications, lab work, x-rays in the tachycardic because "chart is open by (b)(6) in (b)(6) clinic workstation (b)(6)". Called clinic but call went to voice mail. Called it help desk who said call clinic, then said there was nothing they could do. Would not even go to clinic to shut down workstation because number provided did not correspond to their ws ids. Asked our dept administrator to take on problem as we were busy w/ direct care. After about an hour, problem eventually went away, although don't know why. Pt got fluids and some (but not all) drugs, but could not get laboratory or radiology results w/o a valid order in system. It allegedly reported to vendor, no corrective action forthcoming. Concomitant medical products and therapy dates: na.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5055554
• MDR Report Key: 5018380
• Date Received: 2015-08-17
• Date of Report: 2015-08-17
• Date of Event: 2015-01-21
• Date Added to Maude: 2015-08-20
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ASAP MODULE OF EMR
• Generic Name: EMR ORDER ENTRY
• Product Code: MMH
• Date Received: 2015-08-17
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EPIC
• Manufacturer Address: VERONA WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2015-08-17