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U.S. Department of Health and Human Services

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

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® CLEAR CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameMICROCLAVE® CLEAR CONNECTOR
Type of DeviceSET, 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 Key9444465
MDR Text Key170057854
Report Number9617594-2019-00418
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K100434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
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 Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number011-MC100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
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 Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
Treatment
PICC LINE, UNK MFR
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