FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 17390009
·
Received July 25, 2023
Report
- Report Number
- 3006575795-2023-00064
- Event Type
- Malfunction
- Date Received
- July 25, 2023
- Report Date
- July 25, 2023
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020013
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE FLOWRATE TEST WAS PERFORMED ON Z-800F INFUSION PUMP, SERIAL NUMBER (B)(6) BY RUNNING FLOWRATE TESTING PROTOCOL IN THE ABOVE SECTION, THE ISSUE WAS NOT CONFIRMED THE FLOWRATE WAS 118.94 AND THE DEVIATION WAS -2.61 THE PUMP IS OPERATING WITHIN SPECIFICATIONS.
Additional Manufacturer Narrative · 0
RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.
Description of Event or Problem · 0
HEALTHCARE PROFESSIONAL REPORTED "ISSUES WITH NOT INFUSING". MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2344840 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z-800F | 170412400 | 00814371020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |