FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 18951518
·
Received March 21, 2024
Report
- Report Number
- 3006575795-2024-00254
- Event Type
- Malfunction
- Date Received
- March 21, 2024
- Date of Event
- February 27, 2024
- Report Date
- March 19, 2024
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020013
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
PUMP RECEIVED ON 03/04/2024. FUNCTIONAL TESTING WAS DONE ON PUMP ON 03/14/2024. PUMP PASSED ALL TEST ON 03/14/2024. PUMP RAN WITHOUT TUBING AND TEST PASSED AS IT ALARMED "AIR-IN-LINE"; LOADED TUBE INTO THE PUMP AND TEST PASSED AS PMP DOES NOT ALARM "AIR-IN-LINE"; RAN THE PUMP CREATING AIR BUBBLES AND TEST PASED AS PUMP ALARMED "AIR-IN-LINE". PUMP ISSUE WAS NOT DUPLICATED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PUMP INFUSED SOMEONE'S MEDICATION FASTER THAN IT WAS PROGRAMMED BECAUSE HE GOT DONE AN HOUR EARLIER THAN HE SHOULD HAVE. MEDICATION INVOLVED WAS GAMUNEX-C.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1927533 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z-800F | 20150907-SH | 00814371020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Unknown |