FDA Adverse Event
Malfunction
Summary report: N
ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
MDR report key: 15155882
·
Received August 3, 2022
Report
- Report Number
- 3006575795-2022-00022
- Event Type
- Malfunction
- Date Received
- August 3, 2022
- Date of Event
- July 15, 2022
- Report Date
- August 1, 2022
- Manufacturer
- ZYNO MEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00814371020013
- PMA / PMN Number
- K130690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE HEALTH CARE SERVICE PROVIDER WILL HAVE THE PUMP EVALUATED. ZYNO MEDICAL IS WAITING FOR EVALUATION RESULTS.
Description of Event or Problem · 0
ON 07/19/2022, ZYNO MEDICAL RECEIVED A COMPLAINT FROM A HEALTH CARE SERVICE PROVIDER. A FLOW RATE ACCURACY ISSUE WAS REPORTED: "PUMP DELIVERED A 2 HOUR INFUSION IN ONE HOUR." THE DEVICE OPERATOR WAS A REGISTERED NURSE. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1583437 | ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM | LARGE VOLUME INFUSION PUMP | FRN | ZYNO MEDICAL, LLC | Z800F | 20130918-SH | 00814371020013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |