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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 B2 70071-P
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
The failed iv set is being sent to the contract supplier for evaluation. A quality alert has been sent to the contract supplier on 01/18/2017 regarding this issue.
 
Event Description
The user experienced a pinch clamp leakage problem. This is a ltc (long term care) pharmacy. The issue was discovered at pharmacy during routing testing. During routine pump testing, 2 tube sets showed evidence of leaking through closed clamps-one while threaded in a pump (top clamp only), one while hanging attached to liter bag (both upper & lower roller clamps engaged). Over the course of several hours, all fluid in both source bags slowly leaked past the clamps and the bags emptied. This was after the pump test was completed but the tubing was still attached to source bags. Test was with 1000ml bags of ½ ns (normal saline). No patient was involved in the event.
 
Manufacturer Narrative
Zyno medical has received the investigation report from the contract manufacturer on 04/25/2017. The user-reported complaint was not confirmed.
 
Event Description
This is a follow-up for the initially filed mdr (3006575795-2017-00027).
 
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Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL LLC.
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5086502008
MDR Report Key6304813
MDR Text Key66679521
Report Number3006575795-2017-00027
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2019
Device Model NumberB2 70071-P
Device Lot Number16105224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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