MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. KIT COMPOSED OF 4 GANG STOPCOCK W/5 MICROCLAVE® CLEAR, POLE MOUNT, 150 CM EXT W/; STOPCOCK, I.V. SET

Catalog Number 011-MC33416

Device Problem Air/Gas in Device (4062)

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

Event Date 12/13/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The event occurred on an unknown date involving a kit composed of 4 gang stopcock w/5 microclave® clear, pole mount, 150 cm ext w/2 rotating luers (male/male) where it was reported that during administration of a parenteral nutrition, a leak was observed at the red stopcock creating a 50cm bubble at the level of the tubing.There was patient involved but no harm was reported.No additional information was provided.

Manufacturer Narrative

Additional information: b1 - adverse event/product problem.B2 - outcomes attributed to ae.B3 - date of event.D4 - lot #.D4 - expiration date.D10 - product.H1 - type of reportable event.H4 - device mfg date.H6 - adverse event problem.

Event Description

An update was received on (b)(6), 2022 involving a patient death, but the customer stated that the death was not due to a malfunction, rather this malfunction was recurrent.It was reported that there was a delay in therapy of about 1h.There was no medical intervention, but the intravenous treatment was stopped.The event occurred on (b)(6), 2022 around 09:30h/ 10:00h.However, the administration the day before, on (b)(6), 2022, at 16:09 for over 24 hours; speed 41.66ml/h, with nutrition olimel 1l + 2g potassium + 250mg pyridoxine + 500mg thiamine.The device was primed before use but was not installed.The pump in use was fresenius vial, module mvp ms orchestra.The pump did not alarm for air in line, because, as noted in the photo, the 50 cm bubble is after the manifold and after the pump.The air bubbles were not in contact with the patient.Very fragile patient on the general level, died the next day.No additional information was provided.

Manufacturer Narrative

Received one used.List#: 011-mc33416, kit composed of 4 gang stopcock w/5 microclave® clear, pole mount, 150 cm ext w/2 rotating luers (male/male); lot#: 6569745.Received one used.Infusion set.Received two photos showing air in line.Received a third photo showing leakage at the connection near the red stop cock on the manifold.The complaint of leakage/air in line can be confirmed.As received the manifold was connected to a male luer of an unknown infusion set.There were multiple cracks and crazing observed on the female luer.The largest crack propagated axially down the female luer then had a gradual curve in the crack near the stop cock on the manifold.This curving of the crack is typical of an external bending force.No damages observed on the microclaves.The probable cause of the crack and subsequent leakage is due to unintentional external bending force exacerbated by environmental stress during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: KIT COMPOSED OF 4 GANG STOPCOCK W/5 MICROCLAVE® CLEAR, POLE MOUNT, 150 CM EXT W/
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16061178
• MDR Text Key: 307578949
• Report Number: 9617594-2022-00337
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33416
• Device Lot Number: 6569745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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: 1L NUTRITION OLIMEL, MFR UNK.; 250MG PYRIDOXINE, MFR UNK.; 2G POTASSIUM, MFR UNK.; 500MG THIAMINE, MFR UNK.; PARENTERAL NUTRITION, MFR UNK.; PUMP MODULE MVP MS ORCHESTRA: FRESENIUS MFR.
• Patient Outcome(s): Death