FDA Adverse Event
Malfunction
Summary report: N
FREEDOM 50 PUMP
MDR report key: 20109124
·
Received August 29, 2024
Report
- Report Number
- MW5159072
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Report Date
- August 22, 2024
- Manufacturer
- KORU MEDICAL SYSTEMS, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. PT REPORTED FREEDOM 60 PUMP BROKE. (NO FURTHER DETAILS AS TO HOW PUMP WAS BROKEN PROVIDED.) PT REQUESTED A NEW PUMP BE OVERNIGHTED. UNKNOWN IF PT WAS IN PROCESS OF AN INFUSION OR GETTING READY TO DO AN INFUSION. UNKNOWN IF PT MISSED A DOSE, IF THERE WAS AN INTERRUPTION TO THERAPY OR IF ADVERSE EVENT(S) RESULTED DUE TO PRODUCT ISSUE. PHARMACY REPLACING DEVICE. DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN. PUMP SERIAL NUMBER AND MAINTENANCE DUE DATE UNKNOWN. NO FURTHER INFO. REPORTED TO (B)(6) BY PATIENT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1369502 | FREEDOM 50 PUMP | PUMP, INFUSION | FRN | KORU MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | CUTAQUIG SDV. |