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

Model Number	Z-800
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected pump to perform the investigation.
Event or Problem Description
On 8/22/2019, a distributor of zyno medical reported a flow rate issue of the pump.A user facility representative contacted the distributor on 8/22/2019, stating that "pump (b)(4) was infusing too quickly." she stated "sometimes it says there's more in the bag than there actually is." she also stated that "sometimes the pump would complete an infusion and there would still be a significant amount of medication left in the bag." medication used was gammaked.A patient was involved, but there was no harm.The device operator was a registered nurse.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2019-00025).
Additional Manufacturer Narrative
The affected pump returned from the customer was tested by the service provider.Zyno medical received the evaluation report from the service provider on 11/22/2019.The reported "flow rate" issue couldn't be repeated.The pump passed the test, and the flow rate was within specification.The complaint couldn't be confirmed.

• 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: 8936114
• Report Number: 3006575795-2019-00025
• Device Sequence Number: 1812456
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Z-800
• Device Catalogue Number: Z-800
• Device Lot Number: 20130123-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1