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

Model Number Z-800F

Device Problems No Audible Alarm (1019); Backflow (1064)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Return of the device has been requested.  as of the date of this report, device has not been returned.

Event Description

A healthcare professional reported an issue with an infusion pump.Reportedly the pump did not alarm when the medication was not infusing, resulting in blood backing up in the tubing all the way to the needleless cap.The pump was reported to have been removed from use.A good faith effort was initiated for additional information the health care professional reported "the drip chamber was not empty, the tubing had been primed completely with the medication orencia".No patient injury was reported.No further information was provided as of the date of this report.

• 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: 16771650
• MDR Text Key: 313614433
• Report Number: 3006575795-2023-00010
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/19/2023

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: Z-800F
• Device Catalogue Number: Z-800F
• Device Lot Number: 150527-330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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