FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 18983169
·
Received March 26, 2024
Report
- Report Number
- 3006575795-2024-00064
- Event Type
- Malfunction
- Date Received
- March 26, 2024
- Date of Event
- March 8, 2024
- Report Date
- May 14, 2024
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020037
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THIS FOLLOW UP MDR REPORT IS A CORRECTION OF INITIAL REPORT 3006575795-2024-00064. THE INTIIAL REPORT HAD THE INCORRECT DATE RECEIVED BY MANUFACTURER OF MARCH 8, 2024. THE CORRECT DATE RECEIVED BY MANUFACTURER IS MARCH 11, 2024. THIS DATE IS REFLECTED IN THE PRODUCT COMPLAINT (2024-264). ALL OTHER INFORMATION PROVIDED IN THE INITIAL REPORT IS ACCURATE.
Additional Manufacturer Narrative · 0
ON 03/08/2024, DURING A SERVICING ACTIVITIES OF ZYNO MEDICAL DEVICES, INCLUDING PREVENTIVE MAINTENANCE, THIS PUMP WITH S/N (B)(6) WAS FOUND TO HAVE: FLOW RATE OFFSET %, -1, 5 B.F.
Description of Event or Problem · 0
DURING SERVICING ACTIVITIES OF ZYNO MEDICAL DEVICES, INCLUDING PREVENTIVE MAINTENANCE, THIS PUMP WITH S/N (B)(6) WAS ALLEGED TO HAVE: FLOW RATE OFFSET %, -1, 5 B.F.ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493170 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP, | FRN | ZYNO MEDICAL, LLC | Z800 | 201016280 | 00814371020037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |