MAUDE Adverse Event Report: ICU MEDICAL ICU MEDICAL MONITOR KIT; FLUSH DEVICE: 46111-18

Model Number 46111-18

Device Problems Disconnection (1171); Stopcock valve, failure of (2304); Blood pooling (2318)

Patient Problem Cardiac Arrest (1762)

Event Date 07/17/2015

Event Type  Death  

Event Description

Patient assessed due to monitor alarming 5: 55p.Large amount of blood noted from femoral introducer due to stopcock/blue pressure cap disconnect.Patient went into pea arrest and cpr started.Return of spontaneous circulation following acls.Blood products required.Patient had a second arrest and could not be resuscitated.Ceased to breath at 10:13 pm.Ref mfr #(b)(4).

• Brand Name: ICU MEDICAL MONITOR KIT
• Type of Device: FLUSH DEVICE: 46111-18
• Manufacturer (Section D): ICU MEDICAL; 951 calle amanecer ; san clemente CA 92673
• MDR Report Key: 4995380
• MDR Text Key: 23142811
• Report Number: 4995380
• Device Sequence Number: 1
• Product Code: DRS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 46111-18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2015
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR