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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 Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/03/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The user-reported complaint was not confirmed.The user did not save the affected iv set as it was used for chemotherapy, and it was not sent to zyno medical for evaluation.
 
Event or Problem Description
The user reported that the iv set had a broken filter.The tubing was used for chemotherapy on a patient and the solution was taxol."it was noticed at the fifteen minute vital check that there was a puddle of fluid on the floor by the patients treatment chair.Upon further investigation it was noted that this was the filter leaking".No patient harm or injury occurred for this case.
 
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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 Key6494726
Report Number3006575795-2017-00104
Device Sequence Number1049321
Product Code FPA
UDI-Device Identifier00814371020075
UDI-Public00814371020075
Combination Product (Y/N)N
Initial Reporter StateIA
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) 04/10/2017
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 Model NumberA2-80071-DF
Device Lot Number16047450
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/03/2017
Initial Report FDA Received Date04/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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