MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2¿ MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED); STOPCOCK, I.V. SET

Catalog Number	B55005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, regarding a 14" ext set w/4 gang 1o2® manifold w/baseplate experienced leakage that required medical intervention to alleviate drop in blood pressure.The customer reported that the manifold connection at green port spontaneously started to leak while running vasoactive medication (norepinephrine) resulting in drop in patient's systolic blood pressure and addition of other vasoactive meds; phenylephrine infusion initiated.Leak not immediately obvious and discovered with repositioning 1 hour later.Additional vasoactive medication stopped.There was patient involvement, no patient harm reported but there was a delay in therapy.
Additional Manufacturer Narrative
B1 brand name: 14" ext set w/4 gang 1o2¿ manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device was returned for evaluation; however, testing has not yet been completed.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Received one (1) used b55005 ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red) for inspection.No defects or anomalies noted.Each valve was connected to a 36" head height fluid reservoir from the side port, primed and left for 24 hours.There was no leakage.The reported complaint was unable to be replicated or confirmed.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" EXT SET W/4 GANG 1O2¿ MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED)
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21023528
• Report Number: 9617594-2024-01858
• Device Sequence Number: 20924709
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: 00887709010079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B55005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown