MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number Z800F

Device Problems No Audible Alarm (1019); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Batch data reviewed form: (b)(6) 2021 to (b)(6) 2023.A batch record review was completed, and no issues were found.Performance test was performed on z-800f infusion pump, serial number (b)(4), by running a 20ml infusion.When infusion was completed, pump alarmed "infusion completed" and alarm was audible.A second 20ml infusion was performed and it was confirmed that the door open alarm, air in line alarm, and occlusion alarm were triggered and audible.The speaker issue was not confirmed.The pump was operating within specifications.The pump evaluation was completed on (b)(6) 2023.

Event Description

Healthcare professional reported pump "not alarm after the infusion was complete".It was also reported that air entered the patient's line.Tubing was completely empty of fluid.The device did not alarm for air in line.Patient did not require additional treatment.Pump did not have any obvious physical damage.The patient was disconnected.Medication being infused was unknown.No patient injury reported.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Type of Device: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5083158230
• MDR Report Key: 16787579
• MDR Text Key: 314128856
• Report Number: 3006575795-2023-00026
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: Z800F
• Device Lot Number: 20111005-SH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: N/A.