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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAVILYST MEDICAL, INC. NAMIC; OXYGENATOR, CARDIOPULMONARY BYPASS
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NAVILYST MEDICAL, INC. NAMIC; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 70015002
Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Connection Problem (2900); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 07/26/2017
Event Type  malfunction  
Event Description
Nurses have been having difficulty connecting the iv tubing to the stopcock.It has a squeaking noise when screwing the tubing on.It feels like the threading is not properly lining up and once it is connected it is very hard to unscrew it.There also has been leaking of fluids at the connection site.
 
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Brand Name
NAMIC
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
NAVILYST MEDICAL, INC.
10 glens falls technical park
glens falls NY 12801
MDR Report Key6854772
MDR Text Key85637589
Report Number6854772
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/27/2017
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
Device Operator Nurse
Device Expiration Date05/31/2020
Device Catalogue Number70015002
Device Lot Number5196479
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/27/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer07/27/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; IV FLUIDS CONNECTED TO STOPCOCK.; OTHER, SEDATION
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