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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 UNKNOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
The user-reported issues were caused by inadequate priming techniques performed by the user. The user flowed fluid through the iv set without filing the drip chamber first, which caused turbulence and drug waste. The proper way to prime is to close the roller clamp and spike, and then fill the drip chamber to half full, which reduces the turbulence created by the drip chamber connection to the tubing and thus avoid the user-reported issue. A zyno territory manager followed up with the customer on 02/15/2017 and offered a remedy plan. A retraining will be implemented for the user to correct the priming technique.
 
Event Description
The user reported an issue with the iv set during priming. The nurses primed the tubing manually, but continued to get air in line alarms. The user also experienced filter burst on occasions. No patients were involved in this case.
 
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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 Key6379126
MDR Text Key69110353
Report Number3006575795-2017-00058
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
Report Date 03/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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