FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 17552697
·
Received August 15, 2023
Report
- Report Number
- 3006575795-2023-00066
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- July 13, 2023
- Report Date
- August 15, 2023
- Manufacturer
- ZYNO MEDICAL LLC
- Product Code
- FRN
- UDI-DI
- 00814371020037
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.
Additional Manufacturer Narrative · 0
THE FLOWRATE AND VISUAL INSPECTION TESTS TEST WERE PERFORMED ON Z-800WF INFUSION PUMP, SERIAL NUMBER (B)(6) BY RUNNING FLOWRATE TEST AND VISUAL INSPECTION TEST IN THE ABOVE SECTION, THE ISSUE WAS CONFIRMED. POWER FILTER SCREW AND WIRE HOLDER WAS REPLACED. THE PUMP IS OPERATING WITHIN SPECIFICATIONS AND PASSED FLOWRATE WITH 124.04 AND DEVIATION OF .31.
Description of Event or Problem · 0
AN END USER REPORTED THAT A PUMP WAS HAVING ISSUES WITH NOT INFUSING. THE PUMP HAS A WIRE HOLDING THE PLUG IN THE BACK THAT WAS BROKEN. MEDICATION WAS UNKNOWN. INFUSION PARAMETERS WERE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1708552 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL LLC | 190722310 | 00814371020037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |