FDA Adverse Event
Malfunction
Summary report: N
PUMP FREEDOM 60
MDR report key: 10046553
·
Received May 11, 2020
Report
- Report Number
- MW5094452
- Event Type
- Malfunction
- Date Received
- May 11, 2020
- Report Date
- May 6, 2020
- 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
Narratives
Description of Event or Problem · 1
PATIENT REPORTED HAVING TROUBLE WITH HER FREEDOM PUMP DURING HER LAST INFUSION. SOLICITED CALL. NO ADDITIONAL INFORMATION. UNKNOWN ISSUE WITH PUMP. UNKNOWN PUMP SERIAL NUMBER. UNKNOWN IF PRODUCT ON HAND FOR RETURN TO MANUFACTURER. UNKNOWN PUMP MAKE AND MANUFACTURER. UNKNOWN IF ADVERSE EVENT OCCURRED DUE TO PUMP ISSUE. INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA, COMBINED IMMUNODEFICIENCY, UNSPECIFIED. AND DISORDER INVOLVING THE IMMUNE MECHANISM, UNSPECIFIED. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? UNK. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? UNK. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 505403 | PUMP FREEDOM 60 | PUMP, INFUSION | FRN | REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS | F10050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |