MAUDE Adverse Event Report: ICU MEDICAL INC. OPTICATH CATHETER

Model Number 886-50324-07

Device Problem Output Problem (3005)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of the mfg.Lot database for lot# 3256398 (mfg.Date 06/2016) shows (b)(4) units were mfgd., tested, inspected, and released; cites no exception documents.Visual inspection: unit was visually examined no defect was found.Each lumen was observed to have no occlusions or anomalies.Functional testing: the temperature thermistor functioned along with the catheter being able to be calibrated per the dfu.Final analysis summary: the reported complaint could not be determined as it was unclear why the unit was being returned.No defect was found with the catheter.The catheter was able to be calibrated and the thermistor functioned.No failures were observed with any of the lumens.Icu medical wil monitor and trend.

Event Description

Complaint received regarding pressure readings.There was no adverse patient consequences reported.

• Brand Name: OPTICATH CATHETER
• Type of Device: OPTICATH CATHETER
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6638142
• MDR Text Key: 77539438
• Report Number: 2025816-2017-00128
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K061450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

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: Nurse
• Device Expiration Date: 12/01/2017
• Device Model Number: 886-50324-07
• Device Catalogue Number: 886-50324-07
• Device Lot Number: 3256398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1