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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 Z800
Medical Device Problem Codes Device Alarm System (1012); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pump was not returned for evaluation.No root cause was established.
 
Event or Problem Description
On 11/23/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 12/03/2019 and stated that a pump 901717 would not occlude and the volume infusion was too high.There was no patient involvement.No information was provided for the device operator or the medication being infused.
 
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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 Key10978852
Report Number3006575795-2020-00044
Device Sequence Number11573346
Product Code FRN
UDI-Device Identifier00814371020006
UDI-Public00814371020006
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K130690
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source distributor,user facility
Initial Reporter Occupation Other
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 Other
Device Model NumberZ800
Device Catalogue NumberZ-800
Device Lot Number20110815-SH
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 Date12/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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