MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2H7462

Device Problem Failure to Deliver (2338)

Patient Problem Missed Dose (2561)

Event Date 11/26/2017

Event Type  malfunction  

Event Description

Noted full iv bag of vancomycin hanging from iv pole upon entering patient's room.Dose was scheduled to be hung prior day at 2100 and was charted as administered.Dose was not infused.

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 7221168
• MDR Text Key: 98313054
• Report Number: 7221168
• 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: Patient
• Type of Report: Initial
• Report Date: 12/21/2017,01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2H7462
• Device Catalogue Number: 2H7462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• 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: IV PUMP: ALARIS PC CAREFUSION MODEL#8015- THE "BRA
• Patient Age: 68 YR