MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PE LINED TUBING, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142480489
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional 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).
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch where it was reported the infusion by gravity was normal, but when infusing by pump, the pump showed occlusion.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Received one used 142480489 primary plum set for inspection.No damages 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 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 of a proximal occlusion alarm was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 11/7/2023.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 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: 17965609
• Report Number: 9615050-2023-00556
• Device Sequence Number: 17842403
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)251101(10)11352758
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 11/01/2025
• Device Catalogue Number: 142480489
• Device Lot Number: 11352758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: UNSPECIFIED INFUSION PUMP, UNK MFR
• Patient Sex: Unknown