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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP
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ZYNO MEDICAL LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP Back to Search Results
Model Number Z-800
Medical Device Problem Codes Inaccurate Flow Rate (1249); Device Operates Differently Than Expected (2913); Electrical Power Problem (2925)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/21/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pump was found to power on as intended, and the issue of fluctuating flow rate was not witnessed.Pump was found to have a flow rate accuracy of -4.76% which is within the +/-5% flow rate specification.The reported issues were not confirmed.
 
Event or Problem Description
The customer reported flow rate issue and power issue with the device."the pump just flashed and changed the rate in 2 seconds, and then completely wiped it to zero." "it beeps when off.Turns itself off then on again and changes the rates on its own." no patient was involved in this case.
 
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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 Key7593074
Report Number3006575795-2018-00051
Device Sequence Number1814062
Product Code FRN
UDI-Device Identifier00814371020006
UDI-Public00814371020006
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K130690
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 06/01/2018
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 NumberZ-800
Device Catalogue NumberZ-800
Device Lot Number20101005-BJ
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2018
Initial Report FDA Received Date06/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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