MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1424228
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sister samples were sent for the evaluation however, testing has not yet been completed.Additional information e1 - (b)(4).
Event or Problem Description
The event involved a plum 360 pump and occurred on an unspecific date.It was reported that they attempted running different plum sets out of this order and none will run iv fluid through our pumps.A service technician came to our facility to run diagnostics on our plum pumps to make sure it wasn¿t the pump malfunctioning.He ran his own plum set tubing through our pumps, and his tubing did not malfunction.The recent order i received makes the pump throw an error code on start-up of the plum pump.Multiple samples were tested, an estimate of 10-15 samples, with four different pumps but the error persists.The technician tried using a different cassette to those pumps and they worked fine.The affected samples were already discarded but sister samples of the same lot are available for evaluation.Additionally, it was stated that patient involvement happens when they are not able to initiate hydration or medication delivery through the plum pump.They were using plum a+ pumps.The error code is listed in the plum pump manual as n185.The error message reads as: ¿proximal occl a at start up.¿ on the evaluation report by medical equipment services, it stated that they tried different cassettes and circuits in different pumps; they found the new cassettes are consistently failing proximal occlusion, older and cassettes from different stock functioned properly in all units.
Additional Manufacturer Narrative
Received three (3) new 142420489 primary plum sets for inspection.No damages or anomalies noted on any of the sets.Each 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.On one of the sets a proximal occlusion alarm was received.The set was removed and reinserted two more times.There was no alarm on the third test.No errors or alarms on the other sets.The reported complaint of a proximal occlusion alarm could be confirmed on one (1) of the new 142420489 primary plum sets.The probable cause is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, CLAVE Y-SITE, 104 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17299994
• Report Number: 9615050-2023-00236
• Device Sequence Number: 3784918
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237(17)260101(10)13487793
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/15/2023

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: 01/01/2026
• Device Model Number: 1424228
• Device Catalogue Number: 142420489
• Device Lot Number: 13487793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: PLUM 360 INFUSER, ICU MEDICAL INC.; UNSPECIFIED MEDICATION, UNKNOWN MFR
• Patient Sex: Unknown