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). |