MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAM; STOPCOCK, I.V. SET

Model Number	AM3014
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event occurred on an unknown date involving a 26" ext set w/3-port nanoclave® manifold, check valve, 2 microclave® clear, clamp, luer lock where it was reported that the rn noted the patient¿s blood pressure decreased significantly while she was assisting another patient.Upon arrival at the bedside, the manifold piece had disconnected from the manifold, causing the vasopressor to subsequently into the floor instead of the patient.The patient complained of unwell feeling due to a significant drop in blood pressure due to unintended interruption of medication.There was a patient involvement but no report of patient harm.
Additional Manufacturer Narrative
No product samples, videos, or photographs were provided for investigation.The lot history 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.Additional information: d9 - device available for eval changed from yes to no.
Event or Problem Description
Update: a medwatch report was received on 20-jul-2022.
Additional Manufacturer Narrative
Received one used list #am3014, 26" ext set w/3-port nanoclave® manifold, check valve, 2 microclave® clear, clamp, luer lock; lot #5162807 with one used extension set w/ sight chamber (unknown list number and unknown lot number) for evaluation.The vasopressor solution residuals were observed in received used device and mating devices.The middle nanoclave was observed to be separated from the manifold.The used device was confirmed to have the center manifold nanoclave port separated at the ultrasonic weld.The weld was visually examined and found to not be fully welded around the perimeter of the nanoclave assembly.The adjacent nanoclave ports were functionally tested and found to exceed specification without separating.The complaint is confirmed with a probable cause of insufficient ultrasonic weld during nanoclave assembly.The device history report (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Additional information: a2, a3, a5, a6, b5, f2, d9 - date returned to mfg initial is 7/14/2022, and f2 - uf/importer report # is (b)(4)- date of event, e4 - initial report sent to fda, and d9 - device available for evaluation.

• Brand Name: 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAM
• 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: 13978115
• Report Number: 9617594-2022-00068
• Device Sequence Number: 5439670
• Product Code: FMG
• UDI-Device Identifier: 00887709086227
• UDI-Public: (01)00887709086227(17)260101(10)5162807
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup,Followup
• Report Date (Section B): 03/11/2022

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 Expiration Date: 01/01/2026
• Device Model Number: AM3014
• Device Catalogue Number: AM3014
• Device Lot Number: 5162807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 07/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/06/2022; 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: VASOPRESSSOR, MFR UNK
• Patient Age: 62 YR
• Patient Sex: Female