MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC; CATHETER, CONTINUOUS FLUSH

Lot Number 5101172

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/12/2021

Event Type  Injury  

Event Description

Patient taken down to mri for abdominal with contrast.Scan was paused for patient movement.Upon entering the room again, rn and mri staff immediately noticed burning smell which was not noticed previously.Upon further investigation, rn noticed arterial bleeding from patients left radial a-line transducer site near the left upper lateral arm.Rn locked a-line to stop the bleeding and further noticed large burn site under the a-line transducer.

• Brand Name: TRANSPAC
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 11494020
• MDR Text Key: 240021883
• Report Number: 11494020
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 5101172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23725 DA
• Patient Weight: 100