MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 41229-02

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Narrative from staff: a pa (pulmonary artery) catheter was placed in the patient overnight.Rn came on shift at 7am next day and noticed the temp probe on the catheter was broken and not able to be connected to the monitor cable.A gold piece inside the temperature port part of the catheter appeared bent/ broken.The pa catheter waveform was appropriate and cvp and pa pressures were able to be calculated.

• Brand Name: ICU MEDICAL
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 12589910
• MDR Text Key: 275190140
• Report Number: 12589910
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 41229-02
• Device Catalogue Number: 412290402
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 38