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

Model Number	B2-70071-DF120
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected set was never returned for evaluation.The distributor confirmed that the customer was not clamping below the filter.The customer stated that, "you were exactly right.I tested it out with clamping it off below the filter, and it did not back up.I have retrained my girls, and we are good.".
Event or Problem Description
On 11/23/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 10/24/2019, and stated that administration set model#: b2-70071-df lot#: 1810012 filter drains back, and then when they turn the pump on there is about 6 inches of air.A patient was involved, but was not harmed, or injured.The device operator was a registered nurse.The medication being infused was unknown.The contract manufacturer of the affected device is podo xingda (tianjin) medical co., ltd.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 10978832
• Report Number: 3006575795-2020-00045
• Device Sequence Number: 14263068
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 10/17/2021
• Device Model Number: B2-70071-DF120
• Device Catalogue Number: B2-70071-DF120
• Device Lot Number: 1810012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1