FDA Adverse Event
Malfunction
Summary report: N
PUMP FREEDOM 60
MDR report key: 12961269
·
Received December 7, 2021
Report
- Report Number
- MW5105926
- Event Type
- Malfunction
- Date Received
- December 7, 2021
- Report Date
- November 29, 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 REPORTS THE INFUSION PUMP BROKE. NO DETAILS WERE GIVEN. IT IS UNKNOWN IF THE PATIENT MISSED A DOSE AND NO ADVERSE DRUG EVENT WAS REPORTED. THE DEFECTIVE PRODUCT 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 'XEMBIFY' AT THE 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 |
|---|---|---|---|---|---|---|---|
| 1853108 | PUMP FREEDOM 60 | PUMP, INFUSION | FRN | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |