MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 123390488

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inch where it was reported the white cap on cassette was loose.The event was noted during infusion.Pump showed ¿air in line¿ during infusion, when healthcare provider removed the cassette from pump, the white cap lost connection automatically.There was patient involvement with no patient harm.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.E1 initial reporter phone number: ext.(b)(6).

Manufacturer Narrative

Received one used 123390488 primary plum set attached to a bag spike adaptor w/ spiros.As received the white cap on the secondary port of the cassette was securely on the cassette.The set was attached to an icu medical provided iv bag, primed per packaging directions, and a test infusion of 10 ml at 400 ml/hr as infused per 90.P-1137 was performed.No errors or alarms were generated, and no restrictions were noted.The set was also leak tested per product specification.No leaks were observed.The complaint of air in line alarm could not be replicated or confirmed on the received primary plum set.Additionally, the white cap on the cassette of the set is meant to be removeable, the dfu states " caution: prior to opening door latch, close all clamps on primary and secondary sets or remove secondary container from secondary port and aseptically cap secondary port".The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 12/18/2023.

• Brand Name: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE
• 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: 18313551
• MDR Text Key: 330304779
• Report Number: 9615050-2023-00771
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)260501(10)13588961
• 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: 02/29/2024

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: 123390488
• Device Lot Number: 13588961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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