MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number UC8519

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

Rn backflushed busulfan with saline bag and then clamped light blue clamp to prevent pump from pulling from ns bag.Rn programmed pump for the chemo to go to air, when going to check on the infusion rn noticed that despite clamp being activated the pump continued to pull from ns bag instead of chemo bag.Rn brought another chemo rn to assess tubing and found no error in how tubing was hung by rn.In order for the chemo to run to air, rn had to manually clamp tubing by holding and pinching the iv tubing.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 10470896
• MDR Text Key: 204914912
• Report Number: 10470896
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UC8519
• Device Catalogue Number: UC8519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1