MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problems Break (1069); Crack (1135); Material Separation (1562)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/01/2016

Event Type  malfunction  

Event Description

The manifold broke while repositioning the patient.The device is stiff - it is unclear how it broke, but cracked and separated during patient's assisted movements.Vasopressor, norepinephrine, and dilaudid infusing.The patient dropped his bp while staff scrambled to reconnect the iv infusions, but he was not harmed as a result of this event.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE; 25212 w. illinois route 120; rlt-10; round lake IL 60073
• MDR Report Key: 5899734
• MDR Text Key: 52922690
• Report Number: 5899734
• Device Sequence Number: 1
• Product Code: FMG
• 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: 08/05/2016

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: No Information
• Device Catalogue Number: 2C6218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2016
• 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: THREE GANG 4-WAY LARGE BORE (LIPID RESISTANT) STOP
• Patient Age: 61 YR