MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET

Model Number	B2-70071-D
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the device.
Event or Problem Description
The initial reporter reported an air-in-line missed alarm issue caused by administration set tubing to zyno medical on (b)(6) 2017.The initial reporter forwarded to zyno medical the email from the representative at the user facility sent out on (b)(6) 2017: "we had an incident today with a zyno pump that continued to infuse, after medication was complete.The entire line on the medication was filled with air.I am labeling the pump for evaluation." on (b)(6) 2017 the initial reporter received another email from the nurse involved in this event and forwarded to zyno medical: "(b)(6) 2017 1348: pt stated "there is air in the tubing" and he was pointing his finger to the upper chamber of his gammagard tubing.The bottle of gammagard was noted to be empty.I noted air throughout the iv tubing from the empty 30gm gammagard bottle to the iv site.I withdrew approximately 1ml air with a 3ml syringe from his iv site.Pt verbalized he was feeling fine and denied lightheadedness, dizziness, vision issues, short of breath, chest pain.Pt was instructed if he develops any of these issues to call our office or call 911 if he feels it is urgent.Pt verbalized good understanding of all information given.5gm gammagard bottle started @ 1356.(b)(4) was notified via message.At 1608: f/u call made to pt.Pt states he did feel a little strange earlier but is feeling fine now.States his wife is a nurse and she will keep an eye on him.Will f/u call with pt tomorrow." the initial reporter followed up with more patient information on (b)(6) 2017 that "dob is (b)(6).We also restarted the pump and resumed the infusion.The rate was set at 249 ml / hour.The volume infused was 379 ml.Vtbi was 500 ml.Infusion was on step 5 with 10 minutes left and 57 ml.Air in line setting at 0.4 (standard setting) learned that generally the nurses insert the iv tubing into the pump prior to turning on the pump.The pump is therefore doing the "test" with the iv tubing already in the pump".The initial reporter also mentioned that they will send out a communication to the user facility regarding the correct practice.The infusion pump involved in this event was reported under mdr 3006575795-2017-00336 on (b)(6) 2018.This report mdr 3006575795-2018-00007 addresses the iv set involved in this incident.
Additional Manufacturer Narrative
The reported issue was not confirmed.The affected set was received by zyno medical on 01/09/2018.The device was returned along with a drug vial and was installed within an infusion pump which was reported in mdr 3006575795-2017-00336.The testing was performed on 01/24/2018.During the visual inspection, it was discovered that the set spike was separated from the tubing and was found inside the vial.It was also found that the set was jammed near the air-in-line sensor of the pump.A cut was found on the tubing as approximately 46 inches below the drip chamber, located below the pumping section.Efforts were taken to duplicate similar tubing jam near air in line sensor but were not successful.The reported air-in-line missed alarm issue was not confirmed for the infusion pump (see mdr 3006575795-2017-00336).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00007).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7207894
• Report Number: 3006575795-2018-00007
• Device Sequence Number: 722749
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: B2-70071-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 17052443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR