FDA Adverse Event Injury Summary report: N

REMUNITY PUMP

MDR report key: 16435576 · Received February 23, 2023

Report

Report Number
MW5115135
Event Type
Injury
Date Received
February 23, 2023
Date of Event
December 26, 2022
Report Date
February 17, 2023
Manufacturer
UNITED THERAPEUTICS /DEKA RESEARCH & DEVELOPMENT CORP.
Product Code
QJY
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

REMUNITY PUMPS FOR PULMONARY HYPERTENSION BY UNITED THERAPEUTICS DISTRIBUTOR IS ACCREDO SPECIALTY PHARMACY REMUNITY PUMPS BY UNITED THERAPEUTICS THAT DELIVER LIFE-SUSTAINING REMODULIN DRUG ARE FAILING AT MASSIVE RATES. I HAVE NOW HAD ALL FOUR PUMPS FAIL WITHIN A MONTH AND HALF OF USAGE AND SHOULD LAST MUCH LONGER. FAILURE OF THESE PUMPS HAVE LED TO MYSELF AND OTHER PATIENTS SCRAMBLING TO GET TO A HOSPITAL TO GET AN IV INSERTED WITH DRUG, HAVING SEVERE SIDE EFFECTS DUE TO HALF LIFE OF THE DRUG. ACCREDO THERAPEUTICS IS THE SPECIALTY PHARMACY I HAVE BEEN GETTING THEM FROM. WHEN PUMPS ARE IN USE, WE GET CONSTANT ERROR CODES DUE TO HUMIDITY, TEMP, CASSETTE ISSUES, AIR IN LINE ISSUES, CASSETTE DEPLETED WARNING WHEN IT ISN'T DEPLETED. I HAVE CALLED ACCREDO AND THE ONLY SOLUTION THEY HAVE COME UP WITH IS FOR US TO FACTORY RESET THE PUMPS BY THE PATIENT IN OUR HOMES WHEN WE ARE DESPERATELY SEEKING OUR DRUG AND HAVING ALMOST IMMEDIATE SIDE EFFECTS LIKE NAUSEA, DIARRHEA, CLAMMY DISPOSITION, LIGHTHEADED, THROWING UP. ONCE THE PUMP ALARMS, THERE IS NO WAY TO DELIVER THE DRUG. THIS IS UNACCEPTABLE. ACCREDO HAS NO WORKABLE SOLUTIONS AND THESE PUMPS ARE FAULTY. EVEN AFTER DOING FACTORY RESETS, THEY CONTINUE TO FAIL AND ALARM ON THE NEXT CASSETTE INSERTED AND NEED TO BE SENT BACK TO ACCREDO. THEN WE ARE LEFT ADMITTING OURSELVES TO THE ER OR WAITING 4-5+ HOURS FOR ACCREDO TO COURIER NEW PUMPS TO OUR HOME WHILE RECEIVING NO MEDICATION DURING THIS TIME FRAME (THAT IS IF YOU ARE LUCKY AND LIVE BY AN ACCREDO PHARMACY). FOR FOUR PUMPS TO FAIL WITH ALL HAVING DIFFERENT ERROR CODES AND COMPLICATIONS, SOMETHING HAS TO BE WRONG. ACCREDO HAS ADMITTED THERE HAS BEEN REPORTED ISSUES WITH THE PUMPS AND ERROR CODES, PROBLEMS WITH THE LITHIUM BATTERIES THEY RUN ON AND THEY ARE WORKING ON "TWEAKS" BUT STILL PATIENTS ARE LEFT DEALING WITH THESE FAULTY/FAILING PUMPS IN LIFE THREATENING SITUATIONS. I AM NOT ALONE. THERE IS MANY REPORTS TO ACCREDO OF COMPLAINTS AND COMPLICATIONS WITH THIS PUMP. PLEASE HAVE SOMEONE LOOK INTO THE COMPLICATIONS AT ACCREDO WITH REMUNITY PUMPS. WE DESPERATELY NEED SOLUTIONS. I AM MORE THAN WILLING TO SHARE MY EXPERIENCE AND DOCUMENTATION. WE NEED TO BE GIVEN MORE THAN JUST TWO PUMPS, ALL FOUR OF THE PUMPS I HAVE USED FAILED IN PAIRS (AS DISTRIBUTED) LEAVING ME WITH NO BACK UPS. REF REPORTS: MW5115134, MW5115136, MW5115137.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
799313 REMUNITY PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY UNITED THERAPEUTICS /DEKA RESEARCH & DEVELOPMENT CORP.

Patients

Seq Age Sex Outcome Treatment
1 39 YR Female Life Threatening| R REMODULIN.