MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IV MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Device Problem Disconnection (1171)

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

Event Date 10/26/2018

Event Type  malfunction  

Event Description

While rolling the patient for skin care and turn, the arterial line stopped reading on the monitor.When the patient was returned to the supine position, the art line was found to be disconnected at the blood collection port.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 8114621
• MDR Text Key: 128732780
• Report Number: 8114621
• Device Sequence Number: 0
• Product Code: DRS
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 11/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA