MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® CLEAR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067)

Event Date 08/26/2019

Event Type  Death  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The lot number is unknown, therefore, a device history review cannot be performed.If additional information becomes available a supplemental report will be submitted.

Event Description

The event involved a microclave® clear connector ln 011-mc100 that the customer reported a patient developed multifocal system sepsis.The patient was relatively well-being, living at home, having external support of the nurses for parental fluid uptake for short bowel syndrome prior to the event.The customer stated a peripherally inserted central catheter (picc) line was installed on (b)(6) 2019 and was used with a conventional 3 way tap.The customer stated the conversion to the microclave was on an unknown date that must have been in between the picc installation on (b)(6) 2019 and the rehospitalization for the infection on (b)(6) 2019.The patient was hospitalized on (b)(6) 2019 when the infection was first diagnosed and died on (b)(6) 2019 in the hospital.It is unknown if there were any noticeable defects to the device.

• Brand Name: MICROCLAVE® CLEAR CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9444465
• MDR Text Key: 170057854
• Report Number: 9617594-2019-00418
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PICC LINE, UNK MFR
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 65 YR