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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LARGE BORE STOPCOCK; STOPCOCK, I.V. SET
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BAXTER INTERNATIONAL INC. LARGE BORE STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C6204
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2016
Event Type  malfunction  
Event Description
Pt was on continuous renal replacement therapy (crrt).System was running without issue.At 8 am, rn was doing her assessment and picked up covering of line.While removing the covering, the return line stopcock became disconnected where it joins the catheter to the patient.She quickly reconnected it.No air entered the tubing and there were no untoward complications.The rn asked another nurse to check on the connections -the stopcock and line- and the second rn felt they were both secure.At noon, the patient was being repositioned and the stopcock again became disconnected.The nurse (who had previously checked the connection) quickly reconnected the line.No complications occurred.The patient was repositioned appropriately.The circuit was placed in the recirculate mode and the stopcocks were changed out.
 
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Brand Name
LARGE BORE STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
25212 w. illinois route 120
round lake IL 60073
MDR Report Key6208422
MDR Text Key63400897
Report Number6208422
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number2C6204
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2016
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer12/02/2016
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
DIALYSIS; GAMBRO FILTER SET HF-1000 FOR PRISMAFLEX CRRT MACH
Patient Age66 YR
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