FDA Adverse Event
Malfunction
Summary report: N
Z-800 INFUSION PUMP
MDR report key: 2072594
·
Received April 22, 2011
Report
- Report Number
- 3006575795-2011-00011
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 28, 2011
- Report Date
- April 5, 2011
- Manufacturer
- ZYNO MEDICAL LLC.
- Product Code
- FRN
- PMA / PMN Number
- K100705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL OF THE RETURNED DEVICE INVOLVED IN THIS REPORT BY A ZYNO REP INDICATED THAT THE FLOW RATE ACCURACY IS OUTSIDE OF THE SPECIFIED +/- 5% RANGE. THE PUMP WILL BE RE-CALIBRATED AFTER IT IS REPAIRED. FURTHER ANALYSIS WILL BE PERFORMED FOR ROOT CAUSE INVESTIGATION. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IDENTIFIED AND IMPLEMENTED.
Description of Event or Problem · 1
THE USER FACILITY REPORTED A INSTANCE WHERE A (B)(4) INFUSION PUMP WAS FOUND TO OVER-INFUSE. NO PT WAS INVOLVED.
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 | 20100729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |