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 Codes	Partial Blockage (1065); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e additional contact: (b)(6).
Event or Problem Description
The complaint/event involved a primary plumset, pe lined tubing, 107 inch that reportedly generated an n185 (cassette test failure) alarm when attempted on each of five infusion pumps during infusion.There were no issues with the 5 pumps, as the pumps worked fine with other sets.The solution/medicine involved was amiodarone/ntg.There were no obvious defects noted on the tubing set (no cracks or breaks, holes, cuts, tears or any other defects).The tubing set was replaced, and therapy resumed.The products were stored in the air-conditioned room in the hospital and were not exposed to extreme temperature.There was no report of human harm.
Additional Manufacturer Narrative
Received one (1) 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.Received the n185 proximal occlusion alarm at startup.The reported complaint of a proximal occlusion alarm can be confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 10jan2024.

• 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: 18451628
• Report Number: 9615050-2024-00017
• Device Sequence Number: 7566955
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/07/2024
• 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: 5 UNSPECIFIED INFUSION PUMPS, MFR UNK.; AMIODARONE/NTG, MFR UNK.
• Patient Sex: Unknown