MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING; STOPCOCK, I.V. SET

Model Number	AM6109
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer which was reported to have leaked during patient infusion on an infant.It was reported that due to the leaking tubing, the baby had an acute blood pressure drop despite increased drip rate and dosing returned to infant's baseline once the tubing was replaced.There was a delay in therapy for approximately 30 minutes of ineffective blood pressure drip/iv nutrition infusion.There was a continuous infusion of total parenteral nutrition (tpn), fentanyl, dopamine, norepinephrine, and omegavan.The medication came in contact with the patient.The customer also noted twisting of connection lock between manifold and manifold tubing.
Additional Manufacturer Narrative
One used 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer was returned for evaluation with drug residuals observed.As received no physical damage or abnormality were observed, no matting device was returned.A photo sample was also received showing the defective product with an arrow indicating where the leaking happened.The set was primed at gravity pressure, using hydrostatic pressure pump and a leak was observed between adaptor fill and manifold.Complaint of leaks can be confirmed, the probable cause of the leakage was due an incomplete insertion between adaptor fill and manifold during manufacturing process.The device history review was performed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
• 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: 16857085
• Report Number: 9617594-2023-00170
• Device Sequence Number: 3429222
• Product Code: FMG
• UDI-Device Identifier: 00887709077645
• UDI-Public: (01)00887709077645(17)271001(10)11001834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AM6109
• Device Catalogue Number: AM6109
• Device Lot Number: 11001834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: DOPAMINE, MFR UNK.; FENTANYL, MFR UNK.; NOREPINEPHRINE, MFR UNK.; OMEGAVAN, MFR UNK.; TOTAL PARENTERAL NUTRITION, MFR UNK.
• Patient Sex: Unknown