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	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, on an unknown date, a primary plumset, pe lined tubing, 107 inch generated an alarm, for the pump in use, at the time of the event.Healthcare providers replaced the pump, but the issue remained.They replaced the set and therapy resumed.There was.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.Additional information: e1: (b)(6).
Additional Manufacturer Narrative
Received one (1) used 142480489 primary plumset for inspection.No damages or anomalies were observed.The product 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 was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 10/20/2023.

• 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: 17849285
• Report Number: 9615050-2023-00488
• Device Sequence Number: 11842464
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 08/31/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/30/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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 INFION PUMP, UKN MFR
• Patient Sex: Unknown