FDA Adverse Event Injury Summary report: N

REMUNITY PUMP

MDR report key: 20312333 · Received September 25, 2024

Report

Report Number
MW5160144
Event Type
Injury
Date Received
September 25, 2024
Report Date
September 23, 2024
Manufacturer
UNKNOWN
Product Code
QJY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ADDITIONAL INFO RECEIVED FROM THE REPORTER ON 9/30/2024 FOR A REPORT NUMBER MW5160144. FOLLOW UP. PT REPORTS THAT THEY ARE CURRENTLY HOSPITALIZED AND THEY HAVE BEEN SWITCHED TO IV REMODULIN. PT HOSPITALIZED DUE TO PREVIOUSLY REPORTED REMUNITY PUMP MALFUNCTION (NO NEW INFO); ADMITTANCE DATE 0 CURRENT LENGTH OF STAY IS UNKNOWN. PT STATES THAT THEY CB NOT WANT TO GO BACK ON SQ REMUNITY SELF-FILL. PT REPORTS THAT THE MD WILL LET THE PHARMACY KNOW HOW TO PROCEED. NO FURTHER INFO, DETAILS, OR DATES AVAILABLE. PREVIOUS SQ REMUNITY SELF-FILL PT, CURRENT IV REMODULIN PT. PT STARTED USING REMUNITY DEVICE (B)(6) 2023. WINREVAIR DOSING AND FREQUENCY: INJECT 0.6ML UNDER THE SKIN FOR ONE DOSE, THEN INCREASE TO 1.4ML FOR TARGET DOSE AFTER 3 WEEKS. EACH DOSE SHOULD BE GIVEN 3 WEEKS APART. MAINTENANCE DOSING HAS NOT YET BEGUN.

Description of Event or Problem · 0

(B)(6) RN FROM THE (B)(6) HOSPITAL ER FROM (B)(6). PT (PATIENT) WAS IN THE HOSPITAL DUE TO MALFUNCTION OF HER REMUNITY PUMP AND THAT SHE IS BEING ADMINISTERED THE MEDICATION (REMODULIN) IN THE HOSPITAL. DATE OF ADMITTANCE/ DISCHARGE OR LENGTH OF HOSPITALIZATION IS UNKNOWN. UNKNOWN IF MD AWARE. NO FURTHER INFO/DETAILS OR DATES AVAILABLE. SQ REMUNITY SELF-FILL PT. PT STARTED USING REMUNITY DEVICE (B)(6) 2023. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1052916 REMUNITY PUMP INFUSION PUMP QJY UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 NA Female Hospitalization ADEMPAS.| AMBRISENTAN | REMODULIN MDV.| WINREVAIR SDV (PAP).