MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET, 4 GANG 4-WAY STOPCOCKS W/BASEPLATE, 4 REMV MICROCLAVE® CLE; STOPCOCK, I.V. SET

Catalog Number MC33324

Device Problem Separation Failure (2547)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The 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.The device history report was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Initial reporter: fax: (b)(6).

Event Description

The event involved a 8¿ smallbore ext set, 4 gang 4-way stopcocks w/baseplate, 4 remv microclave® clear, clamp, rotating luer which was reported to have separated at the connector during patient infusion.The microclave stayed on the stopcock but the primary line was disconnected; the exact location on tubing was at the end of the primary line.The set up was a dextrose 5% in water into the main port in the stopcock and the levophed was on the port closest to the patient.Nothing else was connected to the line.The customer also stated that the connections were tightened and there was no defect noted.The customer reported that the patient's blood pressure was dropping and they tried to increase levophed with no effect; the connection was checked and it was observed that the levophed line had become disconnected from tree.The patient had low blood pressure for a short period of time.The customer reported that there was no blood loss or bleed back and there was no delay in therapy that was critical to the patient.

• Brand Name: 8" SMALLBORE EXT SET, 4 GANG 4-WAY STOPCOCKS W/BASEPLATE, 4 REMV MICROCLAVE® CLE
• Type of Device: 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: 16378349
• MDR Text Key: 309594390
• Report Number: 9617594-2023-00078
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037731
• UDI-Public: (01)00887709037731(17)260901(10)5619250
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33324
• Device Lot Number: 5619250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LEVOPHED, MFR UNK.