FDA.reportPublic FDA data

MAUDE MDR 6872350

MDR report key
6872350
Report number
1218950-2017-06448
Event key
0
Event type
3
Date of event
2017-09-13
Date received
2017-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. WENDY CHADBOURNE
Address
3000 MINUTEMAN ROAD ANDOVER MA 01810 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0CLINICAL INFORMATION MANAGEMENT SYSTEMPHILIPS MEDICAL SYSTEMSDXJ866148.Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-1801. O

Event Narratives#

N

Patient 1

SERIAL # NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION IS UNKNOWN AT THE PRESENT TIME.

D

Patient 1

IT WAS REPORTED THAT A PATIENT SUFFERED A HEART ATTACK AFTER ORDERS FOR LIDOCAINE WERE ADMINISTERED. THE CUSTOMER CONCERNS ARE IN REGARDS TO ICCA'S FUNCTIONALITY FOR SHORT ORDER DRUG CONFIGURATION.

N

Patient 1

THE CUSTOMER CONCERNS ARE IN REGARDS TO ICCA'S FUNCTIONALITY FOR "SHORT ORDER DRUG CONFIGURATION". THE CUSTOMER HAS DESCRIBED THAT LIDOCAINE TOXICITY OCCURRED IN THEIR REPORT. THE PHILIPS FIELD AND PRODUCT SUPPORT ENGINEERING WERE INFORMED OF THIS INCIDENT THE ISSUE WAS INVESTIGATED VIA CHANGE REQUEST (CR) 31085. THE OCCURRENCE WAS ATTRIBUTED TO A USER ERROR IN DRUG ORDER CONFIGURATION. ALL CONTINUOUS DRUG INFUSIONS ARE CONFIGURED AND PRESCRIBED USING A SPECIFIC CATEGORY. BUT SOME DRUGS CAN BE ADMINISTERED AS A SHORT (2-4 HOUR) INFUSION. THE DOCTOR SHOULD HAVE PRESCRIBED THIS DRUG USING THE MEDICATIONS ORDER FUNCTION, BUT INSTEAD USED THE CONTINUOUS INFUSION ORDER WHEN THIS IN FACT, WAS NOT A CONTINUOUS INFUSION. ICCA DOES NOT HAVE AN ORDER CATEGORY FOR SHORT INFUSIONS. THE ICCA SYSTEM WAS OPERATING AS DESIGNED. THE DOCTOR DIDN?T USE THE MEDICATION ORDER AND WENT TO DRUG INFUSIONS FOR A SHORT DURATION DRIP ORDER (LESS THAN 4 HOURS), SELECTING THE OTHER INFUSION REGIME INSTEAD OF THE MEDICATION ORDER WHICH WAS CONFIGURED. NO MALFUNCTION OCCURRED; THIS WAS A USE RELATED/MISUSE ISSUE WHICH THE CUSTOMER HAS NOW ACKNOWLEDGED UPON INVESTIGATION BY THE PRODUCT TEAM. : NO MALFUNCTION OCCURRED. ALL CONTINUOUS DRUG INFUSIONS ARE CONFIGURED AND PRESCRIBED USING A SPECIFIC CATEGORY. BUT SOME DRUGS CAN BE ADMINISTERED AS A SHORT (2-4 HOUR) INFUSION. THE DOCTOR SHOULD HAVE PRESCRIBED THIS DRUG USING THE MEDICATIONS ORDER, BUT INSTEAD USED THE CONTINUOUS INFUSION ORDER. ICCA DOES NOT HAVE AN ORDER CATEGORY FOR SHORT INFUSIONS. THE CONCLUSION WAS THAT THIS WAS A USER ERROR AND THE ICCA SYSTEM WORKED AS DESIGNED. THIS ISSUE IS CONSISTENT WITH A MISUSER ISSUE; IMPROPER TRAINING AND/OR IMPROPER PROCEDURES AT THE HOSPITAL. THE CUSTOMER HAS TAKEN FULL RESPONSIBILITY FOR THE ERROR. IT WAS A CONFIGURATION ERROR IN THAT THE PHARMACIST DID NOT APPROVE IT BEFORE IT WAS USED AND THERE WASN?T PROPER TRAINING OF THE STAFF ON THE NEW USE MODEL FOR THE NEW ORDER. .