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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO NEEDLEFREE HEMODIALYSIS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. TEGO NEEDLEFREE HEMODIALYSIS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number NM1000
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/11/2021
Event Type  malfunction  
Event Description
Patient has bilateral renal agenesis (no kidneys) and receives dialysis/ aquapheresis therapy for 9 hours during the day. Rn performed standard procedures for starting therapy, and noted good blood return and flow from patient's left groin catheter prior to hooking up aquapheresis. When therapy initiated, the machine indicated that there was an occlusion in the line. Troubleshooting began, and confirmed that no blood was able to be flushed or withdrawn from line. Md and rns at bedside discussing best options to troubleshoot. Decision made to replace tego needleless access device, which is routinely changed twice a week. Upon removal, the anti-reflux portion of the tego was found completely depressed which caused complete occlusion. This resulted in a significant delay to the start of patient's therapy, and increased risk for the development of blood clots in patient's lines and aquapheresis tubing. This event had minimal temporary harm.
 
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Brand NameTEGO NEEDLEFREE HEMODIALYSIS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key11796670
MDR Text Key249685662
Report Number11796670
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNM1000
Device Catalogue NumberD1000
Device Lot Number5129037
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2021
Event Location Hospital
Date Report to Manufacturer05/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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