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

Catalog Number 42646-06

Device Problem Unable to Obtain Readings (1516)

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

Event Date 02/08/2020

Event Type  malfunction  

Event Description

It was reported that during placement of an arterial line at the bedside, the physician placed the line and had pulsating blood flow to the line.However, staff was unable to obtain blood pressure readings from the bedside monitor.There was no waveform present.All cables and boxes were exchanged but the problem persisted.Finally, the arterial line was removed and replaced with a new one and a waveform was immediately observed.In the interest of safety, other arterial lines of the same lot were removed from shelves.

• Brand Name: SAFESET
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 9933257
• MDR Text Key: 186707537
• Report Number: 9933257
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 42646-06
• Device Lot Number: 4168605
• 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: 02/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA