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

Model Number Z800WF

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Air Embolism (1697); Chest Pain (1776); Dyspnea (1816)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Zyno medical is waiting for the arrival of the affected device.

Event Description

On 03/02/2023, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor and stated that "we have had another incident with pump malfunction continuing to run after the fluid bag was empty and continue to infuse with air in the tubing.The pump did not alarm.I just found out this happened also with a pump in our (b)(6) clinic and then this incident in our (b)(6) clinic.Yesterday's situation in (b)(6) was more serious.The patient experience severe respiratory distress and had to be transported from our clinic to the emergency room.We have of course pulled the pump for inspection." the device operator was a registered nurse.Medication being infused was unknown.

Manufacturer Narrative

Correction to b2: there is no report that the patient was hospitalized.A batch record review was completed, and no issues were found.Performance test was performed on z-800wf infusion pump, serial number (b)(6) by running a 130ml infusion for 3 test protocols, which was ran 5 times each.For test protocol number 1 all 5 infusions alarm air in line as expected.For test protocol number 2 all 5 infusions ran to completion without air in line alarm as expected.For test protocol number 3 all 5 infusions which had a 1-inch bubble introduce alarm air in line as expected.The air in line issue was not confirmed.The pump was operating within specifications.The pump evaluation was completed on 03/17/2023.

Event Description

Healthcare professional reported patient "had difficulty breathing and sharp chest pain.Oxygen was given.Ems (911) was called.Patient was transferred via ambulance to ogden regional emergency for evaluation of possible air embolism." "withdrew 2 ml of air from patient before blood return." it was reported that the pump had no obvious physical damage.1 liter of ns was set to infuse at a rate of 1100ml/hr, pump was programmed to infuse 1100ml.There were no visible alarms or messages.Device was in use for over 1 hour before onset."the entire segment of tubing from infusion pump to patient was full of air.Champagne bubbles found in the tubing still loaded in the pump." "the first step was 360ml/hr with a volume of 130ml (this was for the infusion of dexamethasone in a 100ml bag that was hung through the y site into a primary line of 1000ml of ns) the second step was set at a rate of 1200ml/hr and with a volume of 1100ml-this is trying to take into consideration of the possible overfill of the bag and expecting that the pump would recognize when the bag was empty with air in the line.The air was infused at the end of the normal saline when the bag was empty but there was a little bit of fluid still sitting in the chamber "fooling" the air sensor even though air was moving in front of it." medication being infused was dexamethasone.

• 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: 16513290
• MDR Text Key: 310977794
• Report Number: 3006575795-2023-00006
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00814371020037
• UDI-Public: 00814371020037
• 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,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z800WF
• Device Catalogue Number: Z-800WF
• Device Lot Number: 191227296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 93 KG