FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 19007073
·
Received March 29, 2024
Report
- Report Number
- 3006575795-2024-00336
- Event Type
- Malfunction
- Date Received
- March 29, 2024
- Date of Event
- March 13, 2024
- Report Date
- March 29, 2024
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020013
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ON 03/13/2024, 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 03/13/2024, 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 14 AND FLOW RATE OFFSET % AT POST-REWORK IS5. THIS IS DETERMINED TO BE A FLOWRATE UNKNOWN ISSUE. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING CALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2592075 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z800WF | 20160517-SH | 00814371020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |