MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Underdose (2542); Missed Dose (2561)

Event Date 02/26/2016

Event Type  malfunction  

Event Description

The iv antibiotic invanz medication was scanned and 1st attempt to give was close to noon.Medication was not actually given until two hours later, due to the alaris pump malfunctioning.It is the opinion of this rn that the problem was with the secondary tubing supplied to us by clearlink system/baxter.Two different alaris brain pumps and 3 different chambers were attempted for use to give the iv antibiotics, but the alaris pump continuously stated there was air in the line and would not infuse.Chambers were changed, the lines were bled 3 different times with no bubbles and or air.It was not until the rn completely changed out the tubing and used only the primary line made by carefusion that the alaris pump would accept and infuse the medication.Also, this is not the first time i have heard about issues with the new secondary tubing as i sent an email a few weeks ago to our educator discussing these same issues.

• Brand Name: CLEARLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; rlt-10; round lake IL 60073
• MDR Report Key: 5789802
• MDR Text Key: 49425752
• Report Number: 5789802
• 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: Other
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• 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: 05/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2016
• 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