FDA Adverse Event
Malfunction
Summary report: N
INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
MDR report key: 9315277
·
Received November 13, 2019
Report
- Report Number
- 1318360-2019-00004
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Report Date
- December 10, 2019
- Manufacturer
- REPRO-MED SYSTEMS, INC.
- Product Code
- PKP
- UDI-DI
- 00659443000001
- PMA / PMN Number
- K162613
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ATTACHMENT: [COMPLAINT (B)(4).PDF].
Description of Event or Problem · 0
PATIENT REPORTED TO RMS THEY INFUSE CUVITRU WEEKLY. DOSE IS 20GRAMS/100ML. UTILIZING FREEDOM60 SYRINGE DRIVER, 2400 FLOW RATE TUBING AND 24 GUAGE, 9MM IN TWO SITES. INFUSIONS HAVE BEEN COMPLETING IN 38-40 MINTUES. FLOW RATE CALCULATOR INDICATES INFUSION TIMES SHOULD BE 54 MINUTES.
Description of Event or Problem · 1
PATIENT REPORTED TO RMS THEY INFUSE CUVITRU WEEKLY. DOSE IS 20GRAMS/100ML. UTILIZING FREEDOM60 SYRINGE DRIVER, 2400 FLOW RATE TUBING AND 24 GAUGE, 9MM NEEDLES IN TWO SITES. INFUSIONS HAVE BEEN COMPLETING IN 38-40 MINUTES. FLOW RATE CALCULATOR INDICATES INFUSION TIMES SHOULD BE 54 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108165 | INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM | INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM | PKP | REPRO-MED SYSTEMS, INC. | FREEDOM60 | S.68264 | 00659443000001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |