MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 146870489

Device Problem Obstruction of Flow (2423)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available, a supplemental emdr will be submitted to the fda at that time.

Event Description

The complaint involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch that reportedly generated a proximal occlusion alarm on the plum 360 display.The b line infusion completed and the a line was started.They opened/closed pump, backprimed, and continued to rectify the alarm.A plum 360 infusion pump, ch 16 was used at the time the issue occurred.Although there was patient involvement, there was no human harm.There was an unspecified delay in patient therapy.

Manufacturer Narrative

The complaint of a proximal occlusion alarm was confirmed as a result of a lot history review.The probable cause of the occlusion alarm is related to material variability in cassette diaphragm stiffness which could cause an increase in the frequency of proximal occlusion alarms.The lot history was reviewed and the lot was found to fall under the scope of an existing corrective action that is in process.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia IL
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17779856
• MDR Text Key: 323792831
• Report Number: 9615050-2023-00457
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 146870489
• Device Lot Number: 13518722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2023
• 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: PLUM 360 INF PUMP SN 20386835, MFR ICU MED