MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number MC330419

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.Additional contact information: (b)(6), regulatory affairs/ quality assurance manager.(b)(6) company limited.(b)(6).

Event Description

The event occurred on unknown date involving a 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave® clear, dual check valve, 1.2 micron filter, luer lock where the customer stated that the transfer set was noted to have lipids infusing beyond tubing despite no occlusion alarms on the pump.Once set changed, issue was resolved.Frequency of the problem was first time.There was patient involvement but no adverse event reported.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18115340
• MDR Text Key: 328289668
• Report Number: 9617594-2023-00967
• Device Sequence Number: 1
• Product Code: FMG
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LIPIDS, MFR UNK; UNSPECIFIED PUMP, MFR UNK