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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL LLC. ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET
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ZYNO MEDICAL LLC. ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET Back to Search Results
Model Number A2-80071-DF
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/13/2014
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The iv set was not returned to the manufacturer for evaluation.The initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.
 
Event or Problem Description
The user reported "we have had some major issues with this new tubing.Patient was receiving erbitox and approximately 50 ml of liquid on ground, appeared to originate from filter on tubing.Chemo spill kit was used to manage area per policy.We have had four chemo spills in the past two weeks." no patient injury or harm was involved.
 
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Brand Name
ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Common Device Name
IV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL LLC.
177 pine street
natick MA 01760
MDR Report Key6233051
Report Number3006575795-2016-00021
Device Sequence Number16513198
Product Code FPA
UDI-Device Identifier00814371020075
UDI-Public00814371020075
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K132841
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/09/2017
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 Expiration Date05/01/2017
Device Model NumberA2-80071-DF
Device Lot Number14055090
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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