FDA Adverse Event Injury Summary report: N

EPIC SYSTEM

MDR report key: 9933754 · Received April 7, 2020

Report

Report Number
MW5094062
Event Type
Injury
Date Received
April 7, 2020
Date of Event
February 16, 2020
Report Date
April 5, 2020
Manufacturer
EPIC SYSTEMS CORPORATION
Product Code
OUG
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

ANAPHYLAXIS - EXACERBATED; I HAVE SERIOUS CONCERNS WITH (B)(6) USE OF LACTOSE IN SOLUMEDROL, AS A MEDICATION THAT IS ROUTINELY USED FOR SMALL CHILDREN DURING ALLERGIC REACTIONS OR ANAPHYLAXIS. IT IS MY UNDERSTANDING THAT THERE HAVE BEEN INCIDENTS IN THE PAST WHERE CHILDREN (NOT IN ANAPHYLAXIS) WERE GIVEN THIS MEDICATION AND WENT INTO ANAPHYLAXIS. MY SON, (B)(6) HAD AN ANAPHYLACTIC REACTION TO MILK AFTER HAVING ACCIDENTALLY INGESTED COW'S MILK (HE HAS A DAIRY ALLERGY). HE WAS GIVEN ONE EPI PEN AT HOME BY HIS MOM, ANOTHER IN THE AMBULANCE, AND ANOTHER UPON ARRIVAL AT (B)(6) CAMPUS. (B)(6) RECEIVED ADDITIONAL MEDICATION AT THE HOSPITAL, IN ADDITION TO THE 3RD EPI PEN, THEY STARTED AN IV, AND ADMINISTERED SOLUMEDROL 40MG VIA THE IV. THIS SPECIFIC DOSE OF MEDICATION IS CONTRAINDICATED FOR PATIENTS WITH MILK ALLERGIES, AS IS STATED ON THE MANUFACTURER'S WEBSITE. IT WAS NOT UNTIL MARCH THAT I FOUND OUT, AS (B)(6) MOTHER, THROUGH AN ALLERGY GROUP THAT THIS MEDICATION SHOULD NOT BE GIVEN TO MILK ALLERGIC PATIENTS, AND THAT THERE HAVE BEEN INCIDENTS IN THE PAST WHERE PATIENTS FOR REASONS OTHER THAN ALLERGIES HAVE BEEN TREATED WITH THIS MEDICATION AND IT HAS CAUSED ANAPHYLAXIS. UPON FINDING THIS INFORMATION, I REVIEWED (B)(6) MEDICAL RECORDS VIA (B)(6) AND FOLLOWED UP WITH PATIENT SERVICES AT (B)(6) HOSPITAL TO CONFIRM WHETHER HE RECEIVED THIS SPECIFIC MEDICATION/ DOSAGE OR NOT. THEY CONFIRMED VIA EMAIL ON THURSDAY, MARCH 26TH THAT HE RECEIVED MEDICATION HE SHOULD NOT HAVE RECEIVED. THEY NOTED THAT "UNFORTUNATELY THERE WAS NOT AN ALERT IN OUR EPIC SYSTEM THAT FLAGGED THIS PARTICULAR DOSAGE OF MEDICATION WAS CONTRAINDICATED FOR YOUR SON'S PARTICULAR ALLERGY." DUE TO THIS CORRESPONDENCE, IT IS OUR UNDERSTANDING THAT IT WAS AN ERROR IN THE MEDICAL RECORD SYSTEM THAT LED TO THE ADMINISTRATION OF THIS DANGEROUS MEDICATION TO (B)(6) WHICH COULD HAVE HAD SERIOUS OR POTENTIALLY FATAL OUTCOMES FOR (B)(6). FOR MEDICATIONS WHERE THERE ARE ONGOING MEDICAL ERRORS, AND ALTERNATIVE FILLERS ARE AVAILABLE AND CAN BE USED, I DO NOT UNDERSTAND WHY OUR SON WAS PUT IN DANGER DUE TO A SYSTEM ERROR THAT HAS BEEN RECORDED MULTIPLE TIMES IN THE PAST. FOR THE SAFETY OF OUR SON AND ALL OTHER PATIENTS, I URGE FAST ACTION RELATED TO THIS CONTRAINDICATED INGREDIENT, TO POTENTIALLY SAVE LIVES. THEY WERE NOT ABLE TO CONFIRM FOR US THE FOLLOWING: REVIEW OF OUR SITUATION THEY DID NOT ANSWER THIS: TO BE TOLD WHETHER THERE WAS AN AWARENESS AT THE TIME OF TREATMENT, OR SUBSEQUENT TO THE TIME OF TREATMENT BUT BEFORE THIS INQUIRY, THAT THE MEDICATION HAD BEEN GIVEN INAPPROPRIATELY. IF THERE WAS AWARENESS BY THE HOSPITAL, CLARIFY WHERE IN YOUR PROTOCOLS YOU WOULD HAVE INFORMED US AS THE PARENTS. WE ONLY LOOKED INTO THIS BECAUSE ANOTHER PARENT OF AN ALLERGY CHILD MENTIONED THIS POSSIBLE RISK, AND WE INVESTIGATED ON OUR OWN. AVOIDANCE OF THIS ISSUE IN THE FUTURE THEY DID NOT ANSWER THIS: CONFIRMATION OF WHAT IS BEING DONE, ON A SYSTEM LEVEL, TO ENSURE THAT THIS ERROR NEVER OCCURS WITH THIS OR ANY OTHER MEDICATION. THEY DID NOT ANSWER THIS: CONFIRMATION OF STEPS TAKEN WITH THE MANUFACTURER (IF APPLICABLE) TO FURTHER ENSURE THAT NATIONALLY AND BEYOND, THIS ISSUE IS ADDRESSED. IT IS NOT CLEAR TO US THAT, AT THIS TIME, THE SYSTEM ERROR IN EPIC IS CORRECTED. THIS ERROR IS SERIOUS, AND COULD HAVE HAD A VERY DIFFERENT (FATAL) OUTCOME, GIVEN THE FACT THAT MY SON WAS ALREADY IN SEVERE ANAPHYLAXIS BEFORE THIS MEDICATION WAS ADMINISTERED. WE WANT TO BE SURE THAT THIS MEDICATION IS NOT ISSUED IN ERROR TO ANY OTHER PATIENTS, WITH A DIFFERENT OUTCOME. THE MISSING INFORMATION IN THE EPIC SYSTEM REGARDING THIS MEDICATION CONTRAINDICATED FOR PATIENTS WITH MILK ALLERGY POSES AN IMMEDIATE RISK TO PATIENTS. WE HAVE NO IDEA IF THIS IS LIMITED TO THE (B)(6) MEDICAL CENTER, (B)(6), OR WHAT EXTENT THE SYSTEM IS INCORRECT AND PUTTING LIVES AT RISK. I CAN PROVIDE: HIPPA FORMS (PARENTS), CORRESPONDENCE WITH (B)(6) FROM (B)(6). WE HAVE MEDICAL RECORDS THAT SHOW (B)(6) BLOOD PRESSURE, INCLUDING CONCERNING DATA FROM JUST AFTER HE RECEIVED SOLUMEDROL. HE NEEDED TO BE AIR-LIFTED TO (B)(6) IN (B)(6) FROM (B)(6), AND THIS DECISION IS DOCUMENTED AFTER HE RECEIVED THE SOLUMEDROL MEDICINE THAT IS CONTRA-INDICATED. THESE RECORDS POINT TOWARDS THIS BEING A VERY DANGEROUS USE OF THIS MEDICATION, THAT SHOULD NEVER HAVE BEEN ISSUED TO HIM, AND HE WAS IN CRITICAL CONDITION TO NEED A MED FLIGHT TO (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
396029 EPIC SYSTEM MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 30 MO Hospitalization| L| O