FDA Adverse Event
Malfunction
Summary report: N
PUMP FREEDOM 60
MDR report key: 13059899
·
Received December 20, 2021
Report
- Report Number
- MW5106201
- Event Type
- Malfunction
- Date Received
- December 20, 2021
- Report Date
- December 13, 2021
- Manufacturer
- REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
- 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
SPONTANEOUS COMMUNICATION FROM THE PATIENT WHO REPORTED THAT THE FREEDOM PUMP IS NOT WORKING. THE PATIENT REPORTED THAT THE FREEDOM PUMP WAS MAKING A CLICKING NOISE AND IS NOT PUSHING THE PLUNGE. IT IS UNKNOWN IF THE PATIENT MISSED A DOSE. THERE WAS NO ADVERSE DRUG EVENT REPORTED. THE DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. THE PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. IT IS UNKNOWN IF THE MD IS AWARE. NO FURTHER INFORMATION IS KNOWN. THE PUMP IS USED TO INFUSE HIZENTRA 20% AT ABOVE DOSE AND FREQUENCY. INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINEMIA. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1946468 | PUMP FREEDOM 60 | PUMP, INFUSION | FRN | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |