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

Model Number	Z800
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 12/01/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 12/01/2020 and reported that pump 906404 was infusing medication at the wrong speed.The distributor stated that "she had two pumps have this issue and one was infusing too fast and one was too slow.She does not remember which is which." the device operator was a registered nurse.Medication being infused was remicade.There was a patient involved.The patient was not harmed or injured.
Additional Manufacturer Narrative
The service provider provided the investigation report on 12/21/2020.The actual device was tested by the service provider on 12/08/2020.The device failed the flow rate testing.The flow rate deviation was out of the +/- 5% specification.The reported issue was confirmed.The device was repaired, calibrated and tested to meet full specifications.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00053).

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 11032538
• Report Number: 3006575795-2020-00053
• Device Sequence Number: 1265258
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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 Model Number: Z800
• Device Catalogue Number: Z-800
• Device Lot Number: 20151204-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1