MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® CLEAR NEUTRAL CONNECTOR; ADMINISTRATION SETS AND ACCESSORIES

Model Number 12512-01

Device Problem Defective Component (2292)

Patient Problems Air Embolism (1697); Stroke/CVA (1770)

Event Date 09/30/2022

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for investigation, but it has not yet been received.

Event Description

User facility mandatory medwatch (b)(4) was received that reported an event involving a microclave® clear neutral connector.A patient had a left internal jugular line with triple lumen ports placed for iv infusion.On (b)(6) 2022 the iv tubing was connected to the microclave clear connector that seals with silicone when not in use.On (b)(6) 2022, two days following an infusion of total parenteral nutrition, the patient was diagnosed with bilateral hemispheric strokes due to air emboli.After the stroke, the patient's lines were assessed, and it was discovered that one of the tubing connectors had failed to seal.The patient died following this event.

Manufacturer Narrative

The following additional information was received from the customer on 13-jan-2023: a staff member identified the problem with the connector after the event when the lines were checked to see if there was an issue.The line had been transfusing total parenteral nutrition (tpn) at the time.They stopped the infusion and saw the connector failed to seal.A baxter sigma spectrum infusion pump set was used as mating device.No blood draws were being performed on this microclave.The mating device was an iv tubing to central line, but that tubing was not saved.The customer reported that the connector had remained connected during the entire two days of use.The line was disconnected right after the event when the lines were inspected and the device failed to seal after stopping the tpn.The customer also stated that the clamps on each lumen of the triple lumen catheter were closed when each of these lines were not in use.D9 - date returned to mfg is 18-jan-2023.The device has been received; however, the investigation is not yet complete.

Manufacturer Narrative

Received one used list #12512-01, microclave¿ clear neutral connector; lot #unknown.As received there was evidence of internal leakage on the used microclave connector, as blood residuals were observed between the microclave body and the silicone plug/seal.During inspection of the silicone seal, slit propagation was observed.Functional testing was performed in the form of a vacuum and leak test, and the device passed the functional testing specification.The sample was disassembled to evaluate the silicone seal and the internal spike.The silicone seal had slit propagation typical of access with an incompatible mating device.No mating devices were returned for evaluation.There were infusate residuals and blood rings observed on the internal spike.The probable cause of the damaged seal, stick down, and leakage is unknown.Received two (2) new.List #mc100, microclave¿ clear neutral connector; lot #10371729 which were indicated as sister sample.There was no damages or anomalies noted on the two new samples.Each sample was leak tested per product specification.No leaks observed in the activated and inactivated states.The sample was submitted to a multiple activation test.After 96 repeated activations there was no stick down observed.The returned two (2) new list #mc100, microclave¿ clear neutral connector; lot #10371729 met product specifications.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: MICROCLAVE® CLEAR NEUTRAL CONNECTOR
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• 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: 15835150
• MDR Text Key: 304028397
• Report Number: 9617594-2022-00305
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12512-01
• Device Catalogue Number: 12512-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: TPN-MFR UNK.
• Patient Outcome(s): Death
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 42 KG
• Patient Race: White