MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14018-04
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
The complaint/event involved a primary plum set, single channel cassette, secure lock, 107 inch.It was reported that the facility was having issues with leaking from the device's pop-open valve near the top of the tubing.The tubing set up was a standard sterile procedure/process for spiking the total parenteral nutrition (tpn) bag and connecting the iv fluid/connectors to the patient line.The tubing was replaced and they needed to switch to an alternate fluid because replacement tpn could not be made at the time.
Additional Manufacturer Narrative
Two open/unused and 11 new list #14018-04 primary plum sets were returned by the customer for complaint investigation.As received, there were no damages or anomalies observed on the returned devices.All the sets were leak-tested per specification and no leakage was observed.Each of the open/unused primary plum sets were attached to an icu medical provided iv bag, primed per packaging directions, and a test infusion of 400 ml at 400 ml/hr was run replicating clinical use.No cassette errors, occlusion alarms, or air in line alarms were generated and no restrictions were noted.No leakage was seen.Nothing came out of the closed filter and the solution level on the drip chamber remained the same on both sets.One representative new primary plum set was attached to an icu medical provided iv bag, primed per packaging directions, and a test infusion of 400 ml at 400 ml/hr was run replicating clinical use.No cassette errors, occlusion alarms, or air in line alarms were generated and no restrictions were noted.No leakage was seen.Nothing came out of the closed filter and the solution level on the drip chamber remained the same.The complaint of issues with tubing leaking from the pop open valve was not confirmed during the complaint investigation.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 01feb2024.
Additional Manufacturer Narrative
Updated information can be found in b3.H6 type of investigation should include only b03 and b14.B01 should not be included/selected.

• Brand Name: PRIMARY PLUM SET, SINGLE CHANNEL CASSETTE, SECURE LOCK, 107 INCH
• Common Device Name: 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: 18626467
• Report Number: 9615050-2024-00092
• Device Sequence Number: 7725889
• Product Code: FPA
• UDI-Device Identifier: 10887709101842
• UDI-Public: (01)10887709101842(17)251001(10)9405817
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Catalogue Number: 14018-04
• Device Lot Number: 9405817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/14/2024; 03/22/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/14/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK; UNSPECIFIED PATIENT LINE, MFR UNK
• Patient Sex: Unknown