FDA Adverse Event Injury Summary report: N

REMUNITY PUMP

MDR report key: 18247110 · Received November 30, 2023

Report

Report Number
MW5148637
Event Type
Injury
Date Received
November 30, 2023
Report Date
November 27, 2023
Manufacturer
DEKA RESEARCH & DEVELOPMENT CORP.
Product Code
QJY
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PT REPORTS THAT THEIR REMUNITY PUMP WAS OFF ALL NIGHT [DATE UNKNOWN) DUE TO A PREVIOUSLY REPORTED PUMP ISSUE. PT TURNED IT BACK ON IN THE MORNING, WHICH CAUSED THEM TO BLACK OUT AND BE HOSPITALIZED FOR 4 DAYS. DATES OF NEW PUMP ISSUE, ADVERSE EVENT AND HOSPITAL ADMITTANCE AND DISCHARGE IS UNKNOWN. IT IS UNKNOWN IF PHARMACY: TROUBLESHOOTING OCCURRED FOR NEW PUMP ISSUE. PT ALSO REPORTS TH LOST WEIGHT AND IS NOW 245LBS, SO MD LOWERED THEIR REMODULIN PUMP RATE (DUE TO WEIGHT CHANGE] WHILE THEY WERE HOSPITALIZED. PER PHARMACY DISPENSING SYSTEM, PT REPORTED THEIR WEIGHT AS 2451BS. ON (B)(6) 2023 UNKNOWN IF MD IS AWARE OF ALL EVENTS. NO FURTHER INFO, DETAILS OR DATES AVAILABLE. PT FILLED REMUNITY. PT STARTED USING REMUNITY DEVICE (B)(6) 2023. IT IS UNK IF THE NEW MALFUNCTIONING REMUNITY PUMP IS AVAILABLE FOR RETURN, AS THE SUSPECT DEVICE SERIAL NUMBER WAS NOT REPORTED. IT IS UNK WHICH DEVICE IS MALFUNCTIONING. PER THE PHARMACY DISPENSING SYSTEM, THE FOLLOWING DEVICE SERIAL NUMBERS ARE CURRENTLY CHECKED OUT TO THE PT FOR USE: (B)(6). THE MAINTENANCE DUE DATES ARE UNK. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
732188 REMUNITY PUMP INFUSION PUMP, DRUG SPECIFIC, PHARMACY-FILLED QJY DEKA RESEARCH & DEVELOPMENT CORP.

Patients

Seq Age Sex Outcome Treatment
1 Male Hospitalization ADE VIPAS| REMODULIN MDV| REMTY WNTY RPLMT PUMP KIT