MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC IV MONITORING KIT

Catalog Number 42648-06

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 01/14/2018

Event Type  malfunction  

Event Description

The arterial line became disconnected at a junction point.The line was in use and the patient did have a small amount of blood loss.The monitor was able to sense that there was an arterial line disconnection.This is how the rn was aware of the malfunction.Per site reporter: i contacted customer service and they gave me an email address to email.I was not able to speak to anyone on the phone about this issue.I sent the email.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: TRANSPAC IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 7302225
• MDR Text Key: 101133823
• Report Number: 7302225
• Device Sequence Number: 1
• 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: 01/22/2018,02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 42648-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2018
• 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
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 104