FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 18975280
·
Received March 25, 2024
Report
- Report Number
- 3006575795-2024-00067
- Event Type
- Malfunction
- Date Received
- March 25, 2024
- Date of Event
- March 11, 2024
- Report Date
- March 25, 2024
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020037
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
ON 3/11/2024 FLOWRATE ISSUE WAS OBSERVED AT ZYNO MEDICAL LLC DURING CALIBRATION. THIS ISSUE IS TRACED TO MAINTENACE AS THERE WERE NO PREVENTIVE MAINTENANCE ACTIVITIES PERFORMED DURING 2023.
Description of Event or Problem · 0
ON 03/11/2024, DURING SERVICING ACTIVITIES OF ZYNO MEDICAL DEVICES, THERE WAS AN ISSUE OBSERVED DURING PREVENTIVE MAINTENACE/ CALIBRATION THAT THERE IS A FLOWRATE ISSUE WHERE FLOW RATE OFFSET% AT PRE-REWORK IS 5% AND FLOW RATE OFFET% AT POST-REWORK IS 0% B.F. THIS IS DETERMINED TO BE A FLOWRATE UNKOWN ISSUE. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING CALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409255 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z800WF | 191105292 | 00814371020037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |