MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8 CM (3") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUE; STOPCOCK, I.V. SET

Catalog Number 011-MC33565

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that an 8 cm (3") smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer generated a leak resulting in a patient becoming tachycardic and increasingly hypertensive.During an inspection of the device, the bio-connecter on the octopus device attached to the central line was faulty and leaking through a join in the product therefore not delivering the medication to the patient during an infusion.The medication or intravenous (iv) fluid that was infusing was labetalol.It is unsure how long into the infusion did the leak occur.There was no blood loss or bleed back.The faulty line was replaced.The set up was a normal iv administration.No visible hole, cut, tears or defect noted but leaking through a join in the product.There was a delay in therapy as it was not transfusing correctly.The patient's status did not change due to the event.The patient's status did not change prior to, during or after the event.The event did not prolong the hospital stay of the patient.There were no medical interventions required, only a change of line.There was patient involvement and patient harm reported.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.Additional information: e1: f: (b)(6).

Manufacturer Narrative

Two (2) new samples #011-mc33565 were returned for evaluation.No physical damage or anomalies on the new samples.As received both new samples were tested and primed as per procedure and no leaks, occlusions or anomalies were confirmed after the test.The complaint of leak can be confirmed based on the photo shared by the customer.However, the new samples after testing did not present leaks, without the return of the mating device a probable cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Date returned to mfg: 11/1/2023.

• Brand Name: 8 CM (3") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUE
• 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: 17882232
• MDR Text Key: 325084816
• Report Number: 9617594-2023-00806
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33565
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: LABETALOL, UKN MFR; UNSPECIFIED GRAVITY SET, UKN MFR