MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 29 CM (11") PUR CLEAR/YELLOW SMALLBORE PENTAFUSE EXT SET W/5 MICROCLAVE CLEAR,; STOPCOCK, I.V. SET

Catalog Number 011-MC33552

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a 29 cm (11") pur clear/yellow smallbore pentafuse ext set w/5 microclave® clear, 0.2 micron filter, 6 clamps, rotating luer that had an air in line during blood sampling on a (b)(6) old child, ¿mor-ar¿, on a neonatology unit.It was reported that when collecting blood from a patient¿s umbilical venous catheter from one of the tripod paths, a significant amount of air was coming back up into the sampling syringe with no pressure observed.After checking the permeability of the catheter and the absence of leaks, a second attempt was made with a different syringe and it showed the same issue.The customer also stated that the venous umbilical catheter was in the proper position and no leakage at the umbilicus or at the junctions were present.The sampling syringes have a volume of 5ml and the midwife confirms that it was air and not vacuum because there was no pressure during the sampling.As an immediate measure, the umbilical venous catheter was left in place without blood sampling on the line.The infusion line was replaced completely and tegaderm was installed on each junction to strengthen the permeability of the circuit.The sample was taken on a peripheral line.There was no physical defect noted on the device.The umbilical venous catheter has been removed on (b)(6) 2021.Customer stated, the set up is vygon ch5 umbilical catheter- bipode- filter- tripode-icu medical bi-directional valves.The administered drugs were parenteral nutrition (pediaven 2) and medialipides.There was patient involvement, however, no clinical consequences were noted, no change in the child's state of health, no delay in therapy, no need for medical intervention, no blood loss noted, and no report of adverse event.

Manufacturer Narrative

A photograph was provided and evaluated showing one plum set connected to one extension set, one microclave, and one picc line.No visible damage or anomalies were apparent in the image.Received one used list# 011-mc33552, 29 cm (11") pur clear/yellow smallbore pentafuse ext set w/5 microclave® clear, 0.2 micron filter, 6 clamps, rotating luer (lot# 4147716), one primary plum set clave (list# unknown, lot# unknown), and one microclave (list# unknown, lot# unknown) and was visually inspected.As received, the filter vent material of the list# 011-mc33552 extension set 0.2 micron filter was wetted out with prior infusate.The bag spike of the plum set was returned broken off.Beach marks were present on the fracture location.The probable cause of the broken bag spike is due to an excessive bending force applied during use.The extension set was removed from the plum set for functional testing.The one extension set was primed with water at gravity pressure and then hydrostatic pressure leak tested.No air in the line was replicated or observed during functional testing.During the leak test leakage occurred from multiple locations of the inlet and outlet 0.2 micron filter vent material.This is due to wetting (saturating) of the vent material by the infusate solution during use.The probable cause of the leakage is a temporary or permanent loss of the hydrophobic properties due to the infusate interaction with the vent material during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 29 CM (11") PUR CLEAR/YELLOW SMALLBORE PENTAFUSE EXT SET W/5 MICROCLAVE CLEAR,
• 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
• MDR Report Key: 11599313
• MDR Text Key: 243350735
• Report Number: 9617594-2021-00107
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619072483
• UDI-Public: (01)00840619072483(17)240701(10)4147716
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33552
• Device Lot Number: 4147716
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CH5 UMBILICAL CATHETER, VYGON MFR; MEDIALIPIDES, MFR UNK; PEDIAVEN 2, MFR UNK; SYRINGE 5ML, MFR UNK
• Patient Age: 1 DA