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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 Code Improper Flow or Infusion (2954)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The actual device was tested by the service provider on (b)(6) 2018.The pump met all specifications as intended.The reported issue was not confirmed.
 
Event or Problem Description
On 09/17/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2018, and reported that the pump 903252 was running at 27 ml/hr then stopped on its own, and then started running at 500ml/hr.There was no patient injury or harm.No information was provided for the medication being infused.The operater of the device was a nurse.
 
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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 Key10635294
Report Number3006575795-2020-00010
Device Sequence Number2438787
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,health profession
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/17/2020
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 Model NumberZ800
Device Catalogue NumberZ-800
Device Lot Number20130123-SH
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/17/2020
Initial Report FDA Received Date10/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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