MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Model Number AM3127

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review could not be completed due to the unknown lot number.

Event Description

The report of event was received via a medsun medwatch mandatory reporting uf/importer report # (b)(4) and involved a 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, clamp, luer lock.The report stated: "patient blood pressure acutely dropped.Iv tubing run from pump to patient.Discovered smallbore ext set w/3-port nanoclave manifold was full of blood backing up from central line.One of the connection sites had cracked off.Smallbore ext set w/3-port nanoclave manifold removed from patient and new 4x1 manifold connected with medications.¿ it was reported that blood was backing up from central line, and occurred when the patient was on monitor with an arterial line.The customer reported that the device appeared to have been broken on the subassy, nanoclave manifold, 3 up.The incident occurred in the critical care dept.Of the hospital.The medications that were being infused were vasoporessors, levophed and epinephrine.There was patient involvement, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

The customer returned one new 11" (28 cm) appx 1.1ml, smallbore ext set w/3-port nanoclave¿ manifold, check valve, clave¿ clear, luer lock; was received for evaluation.The set was primed, using hydrostatic pressure pump and no leaks were observed along the manifolds, claves or connections.The complaint of cracks could not be confirmed by investigation.

• Brand Name: 11" (28 CM) APPX 1.1ML, SMALLBORE EXT SET W/3-PORT NANOCLAVE¿ MANIFOLD, CHECK VA
• 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: 17030223
• MDR Text Key: 316224085
• Report Number: 9617594-2023-00220
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AM3127
• Device Catalogue Number: AM3127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE, MFR UNK; LEVOPHED, MFR UNK; UNSPECIFIED CENTRAL LINE, UNK MFR; VASPORESSORS, MFR UNK
• Patient Age: 59 YR
• Patient Sex: Male