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

Model Number 41240-05

Device Problems Break (1069); Material Twisted/Bent (2981); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

Narrative from staff: patient arrived from cath lab with intra-aortic balloon pump and swan in place.Attempting to attach swan cables to monitor and noted temperature cable would not attach.Prongs in yellow temperature cable were bent together inside.Informed provider at bedside of prongs and was told to use a pair of kellys to straighten the prongs.One prong broke off when straightened and others would not fit in monitor cable.Cable would not read with broken off prong.Able to get cvp (central venous pressure), pa (pulmonary artery) numbers but unable to get hemodynamics with broken swan.Notified on call cardiologist.

• 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: 14429810
• MDR Text Key: 291942630
• Report Number: 14429810
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2022

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: Health Professional
• Device Model Number: 41240-05
• Device Catalogue Number: 412400405
• Device Lot Number: 5482396
• 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: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Male
• Patient Weight: 87 KG