FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 17564670
·
Received August 17, 2023
Report
- Report Number
- 3006575795-2023-00079
- Event Type
- Malfunction
- Date Received
- August 17, 2023
- Report Date
- August 16, 2023
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE FLOW RATE TEST WAS PERFORMED ON Z-800WF INFUSION PUMP, SERIAL NUMBER (B)(6) BY RUNNING THE FLOW RATE PROTOCOL IN THE ABOVE SECTION, THE ISSUE WAS NOT CONFIRMED THE PUMP PASSES WITH A 125.97 FLOWRATE ACCURACY AND A DEVIATION OF 0.13. THE PUMP WAS 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
A NURSE REPORTED THAT A PUMP WAS INFUSING FASTER THAN THE MACHINE WAS PROGRAMMED FOR. MEDICATION AND INFUSION PARAMTERS ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1245496 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |