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	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was received for evaluation.No visual defects or anomalies noted.Each used primary plum set 142480489 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, occlusion alarms.Or air in line alarms were generated and no restrictions in flow were observed on any of the sets.The complaint of n185 alarm was unable to be replicated.The complaint of n185 alarm was unable to be replicated but 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.Additional contact information: a-strong co., ltd.(b)(6).Product manager (b)(6).Mobile: (b)(6).Tel : (b)(6).
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch where there customer reported the patient therapy nitroglycerin (ntg) was interrupted due to a n185 alarm on plum a+ infusion pump.No obvious defects were noted on the tubing set like cracks or breaks and no hole, cut, tears or any other defects noted.The tubing was replaced and therapy resumed.The products were stored in the air-conditioned room in the hospital and were not exposed in extreme temperature condition.There was patient involvement and no patient harm.This is report two of two.

• 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: 18753428
• Report Number: 9615050-2024-00150
• Device Sequence Number: 19768246
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/21/2024
• 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: NITROGLYCERIN, NTG MFR UNK.; PLUM A+ INFUSION PUMP, ICU MEDICAL.
• Patient Sex: Unknown