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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 11/10/2014
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The user-reported leaking issue was confirmed.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.The pump involved in this case was filed separately as mdr #3006575795-2016-00009.
 
Event or Problem Description
The user reported "we had an incident.The clamp was closed and the pump did not beep occlusion.Therefore the connection between the tubing and filter created a leak and we had a chemo spill." this is an issue with leaky iv sets.No patient injury or harm was involved in 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 Key6233083
Report Number3006575795-2016-00029
Device Sequence Number907852
Product Code FPA
UDI-Device Identifier00814371020075
UDI-Public00814371020075
Combination Product (Y/N)N
Initial Reporter StateNC
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 Date02/01/2017
Device Model NumberA2-80071-DF
Device Lot Number14026150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2014
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2014
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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