MAUDE Adverse Event Report: ICU MEDICAL INC. CLAVE CONNECTOR; SET ADMINISTRATION, INTRAVASCULAR

Lot Number 1055RYM5000

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 04/19/2018

Event Type  malfunction  

Event Description

Update to ae submitted 4/19/2018 regarding patient being on her way to the hospital due to medication (remodulin) leaking.Lot number for the faulty clave connector is (b)(4).Per the patient, she was told it had a hole hence the blood in the line.Dose or amount: 50ng/kg/min.Frequency: continuous.Route: intravenous.Dates of use: (b)(6) 2017 to current.

• Brand Name: CLAVE CONNECTOR
• Type of Device: SET ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL INC.
• MDR Report Key: 7475525
• MDR Text Key: 107111206
• Report Number: MW5076942
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1055RYM5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR