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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 A2-80017-DF120
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/12/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The leaking issue was confirmed.Affected iv sets are under recall #(b)(4).(b)(4).
 
Event or Problem Description
The user reported "the iv set came apart from the filter and leaked fluid over a surge protector/outlet strip.The surge protector/outlet strip was damaged and almost caused a fire.A patient was involved but there was no adverse effect.".
 
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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 Key6230446
Report Number3006575795-2016-00019
Device Sequence Number13632522
Product Code FPA
UDI-Device Identifier00814371020082
UDI-Public00814371020082
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
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 01/03/2017
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 Date10/01/2017
Device Model NumberA2-80017-DF120
Device Lot Number14106474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2015
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2015
Initial Report FDA Received Date01/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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