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

Model Number 2C8541

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Chemical Exposure (2570)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

A chemotherapy spill occurred from a port on the side of our baxter tubing set.Neither nursing nor the pharmacy staff manipulated this port during compounding, dispensing, or administration.Health care provider have communicated previous similar issues with the product manufacturer and were offered no implementable solutions to prevent a recurrence.Health care providers captured the product number, lot number, and expiration date in our computer system but, unfortunately, health care providers remain unable to access the information due to an ehr glitch.Health care providers were told this will be resolved so hopefully they can provide information later this week.Without being able to confirm, health care provider expects the tubing set used was 2c8541.Again, they'll confirm later this week.Manufacturer response for tubing set of infusion pump, iv pump set continu-flo 10 drops /ml drip rate 105 each tubing 3 ports (per site reporter).Apology from the manufacturer, described by the manufacturer as not a widespread issue with their product but rather isolated events to our hospital.Although this may be the first incident reported to medsun, we have tracked an estimated 8 similar incidents of tubing leaks this rolling calendar year.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15264955
• MDR Text Key: 298310991
• Report Number: 15264955
• 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: 08/02/2022

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 Model Number: 2C8541
• Device Catalogue Number: 2C8541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White