MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140019291

Device Problems Failure to Deliver (2338); Obstruction of Flow (2423)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.D1 full brand name: primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm.

Event Description

The event occurred on an unspecified date and involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm in which the customer reported that the device had an ongoing display of "prox occlusion a startup- open/close door or backprime" notifications.The infusion was reported to stop mid treatment displaying a notification of "power off then on ¿ replace pump if alarm continues".There was patient involvement, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

Received seven (7) used 140019291 primary plum sets for inspection from lot numbers 11286729, 6359741, 11286729, 52302217, 7884749, 5603775, and 786677 for evaluation on 8/8/2023.No defects or anomalies noted.Each set 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, no occlusion alarms were generated, no air in line alarms were generated and no restrictions in flow were observed.The reported complaint could not be confirmed on the reported one (1) used 140019291 primary plum set lot# 11286729.However, the one (1) used 140019291 primary plum set lot# 6359741 can be confirmed based on a lot history review - corrective actions are in progress.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17546168
• MDR Text Key: 321117779
• Report Number: 9615050-2023-00326
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100128
• UDI-Public: (01)10887709100128(17)251101(10)11286729
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 140019291
• Device Lot Number: 11286729
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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