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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 A2-80072
Device Problems Split (2537); Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 01/25/2017
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the affected iv set on 02/17/2017. The returned iv set is being sent to the contract supplier for evaluation. The manufacturer will actively follow up on this investigation.
 
Event Description
The user reported that "we went to infuse a patient with tysabri on one of our zyno pumps. The pump set had a split in the actual tubing and the medication spilled out on the floor of the clean room. " on the follow-up call with a zyno customer service employee, the customer mentioned that the iv set was leaking in the mixing room and was never placed in the pump. No patient injury or harm occurred for this incident.
 
Manufacturer Narrative
The user reported issue was confirmed. The iv set was evaluated by zyno medical and was found to have a split-tubing due to manufacturing defect. Details of the testing can be found in the report. A quality alert has been sent to the contract manufacturer on 04/13/2017.
 
Event Description
This is a follow-up for the initially filed mdr (3006575795-2017-00051).
 
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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 (Section G)
ZYNO MEDICAL, LLC
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5086502008
MDR Report Key6358440
MDR Text Key68417886
Report Number3006575795-2017-00051
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
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberA2-80072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
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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