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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TWO GANG 4-WAY LARGE BORE STOPCOCK MANIFOLD SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION TWO GANG 4-WAY LARGE BORE STOPCOCK MANIFOLD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C6217
Device Problem Break (1069)
Patient Problems Bradycardia (1751); Hypoxia (1918)
Event Date 12/20/2015
Event Type  malfunction  
Event Description
Icu pt was about to be turned but then the double gang stopcock (manifold for continuous renal replacement therapy (crrt)) snapped in half. Pt began to bleed from the return line. She became acutely bradycardic and hypoxic and had to be re-intubated.
 
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Brand NameTWO GANG 4-WAY LARGE BORE STOPCOCK MANIFOLD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
1 baxter pkwy
deerfield IL 60015
MDR Report Key5379250
MDR Text Key36395552
Report Number5379250
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number2C6217
Device Lot NumberUR14L10082
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/05/2016
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer01/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/20/2016 Patient Sequence Number: 1
Treatment
CONTINUOUS RENAL REPLACEMENT THERAPY
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