MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 251 CM (99") EXT SET W/5 GANG STOPCOCK W/6 CLAVE®, 4-WAY STOPCOCK W/CLAVE®; STOPCOCK, I.V. SET

Catalog Number 011-H3677

Device Problem Air/Gas in Device (4062)

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

Event Date 01/15/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.Initial reporter facility name : (b)(6).

Event Description

The event involved a 251 cm (99") ext set w/5 gang stopcock w/6 clave®, 4-way stopcock w/clave® where it was reported there was a presence of air bubbles.The following issue was reported stating the medical device is a secure infusion set-up used as a midline for the infusion of patients in the intensive care.During infusion there was a presence of air bubbles apart from any handling by the liberal nurse.It was observed that the valve at the end of the manifold remained pressed in.The infusion manifold was changed with no clinical consequences to the patient.There was patient involvement, however no report of patient harm.

Event Description

Additional information provided stating there was no delay in therapy, no clinically significant blood loss, and no need for additional medical interventions.There was nothing signal concerning on the patient's condition before, during, and after the incident.After the incident, the replacement of the ramp and the disassembly showed that the rubberized part of the valve on the patient side remained depressed.The medication administered was phytoserum at pse speed 2 ml/h.The ramp was installed around 12 p.M.And incident fortuitously was noted by the nurse at 5 p.M.No intervention by the nurse on the ramp in the meantime.There were air bubbles in a string of more than 70 cm between the ramp and the patient.It was unknown if air bubbles came into contact with the patient.There was no air eliminator filter used because their setting complies with the icu medical assembly proposal.The pump did not trigger the air in line alarm because the air bubble was downstream of the ramp and no air upstream.

Manufacturer Narrative

One 011-h3677 ext set w/5 gang stopcock w/6 claves was confirmed to have one clave on each assembly with a fold over stick down.The fold over stick down and result in leakage and air ingress during use.The probable cause is typical of damage sustained to the clave assembly due to angled or sliding insertion during use.The dfu states: swab and attach administration device by pushing straight into clave/microclave/nanoclave and twisting until secure.The device history review (dhr) for lot 5610996 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.D9 device returned to mfr on 8/29/2023.

• Brand Name: 251 CM (99") EXT SET W/5 GANG STOPCOCK W/6 CLAVE®, 4-WAY STOPCOCK W/CLAVE®
• 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: 16265939
• MDR Text Key: 308398334
• Report Number: 9617594-2023-00048
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3677
• Device Lot Number: 5610996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/02/2023; 09/21/2023
• Supplement Dates FDA Received: 03/01/2023; 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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
• Treatment: PHYTOSERUM, UNK MFR; PUMP FRESENIUS EXELIA