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 No Flow (2991)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.The customer reported that the when they put the tubing in the plum a+ pump, it was alarming n185.The customer reported that the issue was only tubing related and there was no problem with the pumps.Additionally, when they prime the line, the pump keeps beeping 2-3 times and it takes at least 10 minutes to get the pumps to work.The customer also reported that their biomed engineer stated that they took the cartridge from stevens county hospital and attempted to use it on a pump from another facility - it caused error n185.They tested the lot number on a different plum iv pumps at a different facility and it still alarmed the n 185 code.The event occurred during initiation for patients treatment.But no harm was reported as a consequence of this event.

Manufacturer Narrative

The g3 date should have been 2/26/24 and not 12/13/23 as documented in follow up #1 - 9615050-2023-00817-01.

Manufacturer Narrative

One (1) used.List #146870489, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #13547450 was received for evaluation; no visual defects or anomalies noted.The used primary plum set 146870489 was attached to an icu medical provided iv bag, primed per packaging directions and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, occlusion alarms, or air in line alarms were generated and no restrictions in flow were observed.The reported complaint of a proximal occlusion alarm could not be replicated.The complaint of n185 alarm can be confirmed based on lot history.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: 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 ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18413969
• MDR Text Key: 331720958
• Report Number: 9615050-2023-00817
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260401(10)13547450
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

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: 146870489
• Device Lot Number: 13547450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 02/26/2024
• Supplement Dates FDA Received: 03/04/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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: PLUM A+ INFUSION PUMP, ICU MEDICAL.