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

Model Number 2H7462

Device Problem False Positive Result (1227)

Patient Problem Missed Dose (2561)

Event Date 11/25/2017

Event Type  malfunction  

Event Description

Vancomycin marked as given at 21:44; med hung but never infused.Doctor called to notify pharmacy that vanco trough this am is not accurate and asked that we not adjust dose until we get another level.

• 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: 7221167
• MDR Text Key: 98313205
• Report Number: 7221167
• 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
• 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