FDA Adverse Event Injury Summary report: N

REMUNITY PUMP

MDR report key: 20312345 · Received September 25, 2024

Report

Report Number
MW5160145
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
NURSE
Health Professional
*

Narratives

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1052917 REMUNITY PUMP INFUSION PUMP QJY UNKNOWN

Patients

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