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

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.

• Brand Name: TWO GANG 4-WAY LARGE BORE STOPCOCK MANIFOLD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 1 baxter pkwy; deerfield IL 60015
• MDR Report Key: 5379250
• MDR Text Key: 36395552
• Report Number: 5379250
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2C6217
• Device Lot Number: UR14L10082
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2016
• 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 Number: 1
• Treatment: CONTINUOUS RENAL REPLACEMENT THERAPY
• Patient Age: 47 YR