MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PIGGYBACK, BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 103 I; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142510489
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a primary plumset, piggyback, backcheck valve, 2 clave y-sites, secure lock, 103 inch where infusion sets were showing multiple proximal occlusion alarms.There was unknown patient involved and unknown human harm reported.
Additional Manufacturer Narrative
The device has been received.Investigation still pending.
Additional Manufacturer Narrative
A series of pictures were returned showing different types of occlusion alarms as well as the packaging of the affected product.Received one used list #142510489 primary plumset connected to an unknown microclave.No defects or anomalies noted.The 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 cassette errors, occlusion alarms or air in line alarms generated and no restrictions in flow were observed.The complaint of occlusion alarm could not be replicated however, 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.The lot history was reviewed, and corrective actions are in process.

• Brand Name: PRIMARY PLUMSET, PIGGYBACK, BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 103 I
• 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: 18949399
• Report Number: 9615050-2024-00242
• Device Sequence Number: 20604084
• Product Code: FPA
• UDI-Device Identifier: 10887787006480
• UDI-Public: (01)10887787006480(17)260301(10)13564177
• 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): 04/24/2024

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: 03/01/2026
• Device Catalogue Number: 142510489
• Device Lot Number: 13564177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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 INFUSION PUMP, UNK MFR
• Patient Sex: Unknown