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), CHECK; STOPCOCK, I.V. SET

Model Number	B55005
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred in an intensive care unit (icu) and involved a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext.It was reported that a crack/leak was observed on the device when multiple pressors and sedatives had been infusing into the central line of a patient.It was noted that the product was used for less than seven hours when the event occurred.The patient¿s blood pressure decreased drastically, and a patient code resulted.Compressions were performed, the gang bar was replaced, and therapy resumed.There was patient involvement and patient harm reported.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.Although the device has been requested to be returned for evaluation, it has not been received.
Event or Problem Description
The customer provided the following additional information: the patient is female in her mid-50s with a systolic blood pressure (sbp) in the 140s leading to the event.Then, her sbp went down to the 80s.She increased levophed from 14 to 16, rider increased to 20.The sbp then went up to 120s.She decreased levophed back to 14, rider 10.The sbp then went down to 80.She increased the levophed back to 16 rider to 20.The sbp went further down to 60s.She increased levophed to 20, ride to 30.She eventually turned the levophed up to 24 and the rider up to 40.The sbp did not go up and was now in the mid 40s, and she called for help.The medication involved lumen 1 - nstkvo, lumen 2 - nstkvo, lumen 3 - levophed, vasopressin, propofol, fentanyl and rocuronium.
Additional Manufacturer Narrative
Although the defective sample and sister samples were requested to be returned for investigation, there were no product samples returned.A photograph was provided showing a 14" ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext assembly.There were no defects or anomalies observed when examining the photograph that the customer provided.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13715355
• Report Number: 9617594-2022-00049
• Device Sequence Number: 4806749
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: (01)00887709010079(17)261101(10)5695933
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: B55005
• Device Catalogue Number: B55005
• Device Lot Number: 5695933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: CENTRAL LINE, MFR UNK.; FENTANYL.; LEVOPHED, MFR UNK.; PROPOFOL.; ROCURONIUM.; UNSPECIFIED PRESSORS (MEDICATION), MFR UNK.; UNSPECIFIED SEDATIVES, MFR UNK.; VASOPRESSIN.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female