MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142540489
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, but an investigation is not completed.When complete, then a supplemental mdr will be submitted.
Event or Problem Description
An complaint involving a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch experienced air in line.It was stated in the report that the event occurred when setting up the iv pump for infusion.Rn primed filter tubing with panitumumab med, put tubing in iv pump, turned pump on, pump went through its initial checks and alarmed "distal air".Rn discovered the drip chamber had filled all the way up, they only filled halfway, this happened with an already reported incident as well, there was visible air in the tubing below the cassette (distal).Rn also noticed on the cassette, the blue port on the cassette looked different.The center silicone circle was elevated up over the blue port top.This is not how the tubing usually looks.It was removed from the iv pump and sent up to pharmacy to put on new tubing.Patient care was delayed as the entire set had to be sent back up to pharmacy, they had to put a new tubing on drug bag and then tubing was reprimed and sent back down to infusion department.There was patient involvement, no patient harm and there was a delay in therapy.
Additional Manufacturer Narrative
Received one (1) used list #142540489 primary plum set.No significant damage or anomalies were observed.The set was attached to an icu medical provided iv bag, primed per packaging directions, and a test infusion was performed.No cassette errors, occlusion alarms, or air in line alarms were generated and no restrictions in flow were noted.No air was observed in the line.The set was leak tested per specifications.No leakage was observed.The complaint of air in line cannot be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 20242990
• Report Number: 9615050-2024-00682
• Device Sequence Number: 7291522
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)270201(10)13850952
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/14/2024

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 Catalogue Number: 142540489
• Device Lot Number: 13850952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2024
• 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: UNSPECIFIED DRUG , MFR UNK
• Patient Sex: Unknown