FDA Adverse Event
Malfunction
Summary report: N
Z-800 INFUSION PUMP
MDR report key: 2111146
·
Received May 25, 2011
Report
- Report Number
- 3006575795-2011-00017
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- February 25, 2011
- Report Date
- May 23, 2011
- Manufacturer
- ZYNO MEDICAL LLC.
- Product Code
- FRN
- PMA / PMN Number
- K100705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED DEVICE INVOLVED IN THIS REPORT BY A ZYNO REPRESENTATIVE INDICATED THAT THE FLOW RATE IS OUTSIDE OF THE SPECIFIED +-5% ACCURACY. THIS REPORT IS FILED RETROSPECTIVELY AS A RESULT OF AN INTERNAL AUDIT.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE PUMP OVER-INFUSED BUT NO PATIENT WAS INVOLVED. ZYNO HAS REQUESTED; HOWEVER, THE USER FACILITY HAS YET TO PROVIDE DETAILED INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Z-800 INFUSION PUMP | LARGE VOLUME PERISTALTIC INFUSION PUMP | FRN | ZYNO MEDICAL LLC. | Z-800 | 20090910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |