MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONDEHP LS LF PLUMSET-OLCP D-CHAN; ADMINISTRATION SET

Model Number 1468728

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device used in the event was reported as discarded during due diligence activities.In addition, no lot number was provided; therefore, no expiration or manufacturing date can be identified.No additional information is available at this time.

Event Description

It was reported, on an unknown date, that air was being introduced into the administration set and the plum 360 pump being used, during the event, did not alarm.The clinician report included a concern about user facility practices of capping the administration set with curos cap.It was asked if using the curos cap may be compromising the device.There was patient involvement but there was no report of harm or medical intervention as a result of the event.No additional information is known at this time.

• Brand Name: NONDEHP LS LF PLUMSET-OLCP D-CHAN
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: emily arnould ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8574097
• MDR Text Key: 143850496
• Report Number: 9615050-2019-00139
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2019

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: 1468728
• Device Catalogue Number: 146870438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CUROS CAP; PLUM 360