MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV; STOPCOCK, I.V. SET

Catalog Number AM3020

Device Problem Inaccurate Delivery (2339)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e end user facility contacts: (b)(6).Inventory control specialist - surgery gsrmc.O: (b)(6).C: (b)(6).(b)(6).

Event Description

The event occurred on an unspecified date and involved a 112" 15 drop primary set w/3 microclave®, 3-port nanoclave® manifold, check valve, rotating luer.The anesthesia provider reported that the device had check/regurgitation valve failures preventing in-line pharmaceutical delivery via syringe from traveling upstream into spiked fluid bags (usually containing crystalloids).Some of the facility's medications are opaque and easily observed in the tubing.However, for medications that are not opaque, it is impossible to determine the direction of travel (where there is less resistance), usually toward the spiked fluids.This would render the infusion to be ineffective.The customer reported that it would be even worse if a patient received part of a pharmaceutical medication at strength, therefore only achieving a partial desired reaction.For example, a patient could become unconscious during the anesthesia induction, but not at the depth needed for surgery.Subsequently, a partial dose may provide only a portion of the desired effect, leaving the provider unable to determine treatment plan efficacy.The complainant further indicated that subsequent potential catastrophic outcomes could occur.An in-house trial alleged a 30% failure within the reported lot number.There was no actual or specific human harm reported.

Manufacturer Narrative

A diagram was provided showing the most proximal check valve as the one in question.Three partial am3020 assemblies were returned with the entire set below the most proximal y-clave missing.The check valve upstream of the proximal y-clave can be tested for functionality.The three partial am3020 assemblies were tested for check valve capability.On each of the returns, pressure testing was performed by clamping off the line distal to the y-clave to test the check valve on the y-port of the y-clave.There was no leakage past the check valve and the check valves met product performance expectations.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 8/3/2023.

• Brand Name: 112" 15 DROP PRIMARY SET W/3 MICROCLAVE®, 3-PORT NANOCLAVE® MANIFOLD, CHECK VALV
• 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: 17396919
• MDR Text Key: 320617875
• Report Number: 9617594-2023-00435
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709088511
• UDI-Public: (01)00887709088511(17)280501(10)13642224
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AM3020
• Device Lot Number: 13642224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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