MAUDE Adverse Event Report: ICU MEDICAL, INC. REM MICROCLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 07/07/2016

Event Type  malfunction  

Event Description

Iv pump set up for iv infusion with ivpb.The pump alarmed for air-in-line.The rn checked tubing and verified.Detected air and iv fluids throughout tubing, including pressure infusion extension set with remv microclave clear rotating luer.Unsure if air reached patient.Iv infusion pump was alarming, but air and iv fluids was detected intermittently throughout entire tubing line.The pump was removed from room and exchanged for new infusion pump.Work order completed by rn.

• Brand Name: REM MICROCLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6036454
• MDR Text Key: 57734621
• Report Number: 6036454
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR