MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142730490

Device Problem No Flow (2991)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation; however, a photo was provided.Investigation is pending.

Event Description

The event involved a plum set where it was reported when plum set was loaded into pump device, pump alarm showed tube occlusion.The tubing was checked and confirmed no occlusion, but the alarm continued.The issue remained after replacing 3 pumps.The set was then then replaced, and infusion returned normal.There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

A photo was returned showing the set in a plastic bag.No damages or anomalies noted.The reported complaint of a proximal occlusion alarm can be confirmed based on 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.Corrective actions are in process.

• Brand Name: PLUM BURETTE CLAVE SITES 114IN NDEHP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18614740
• MDR Text Key: 334844937
• Report Number: 9615050-2024-00084
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)260501(10)13579593
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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 Catalogue Number: 142730490
• Device Lot Number: 13579593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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: UNSPECIFIED INFUSION PUMP, UNK MFR