MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC IV MONITORING KIT; CATHETER, CONTINUOUS FLUSH

Device Problem Occlusion Within Device (1423)

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

Event Date 02/05/2018

Event Type  malfunction  

Event Description

Pump with uac line ringing occlusion patient side.Line flushes well, no clamps on the line.New fluid and lines hung and no longer ringing occlusion.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7281826
• MDR Text Key: 100424930
• Report Number: 7281826
• Device Sequence Number: 0
• Product Code: DRS
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1