MAUDE Adverse Event Report: ICU MEDICAL INC. 30 ML FLUSH MONITORING KIT #3; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 46010-34

Device Problems Air Leak (1008); Device Alarm System (1012); Loose or Intermittent Connection (1371)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 06/26/2014

Event Type  Death  

Event Description

Previously healthy patient admitted to outside hospital three months ago with multilobar pneumonia.Pt placed on v-v ecmo approximately 4 days after admission to outside facility.Transferred to this facility on ecmo approximately one month later for lung transplant evaluation and has remained on ecmo.Approximately 2 months after transfer to this facility, 2 rns performing routine q 12 hr flush and zeroing of the ecmo circuit pressure lines.Immediately after zeroing line on venous side of ecmo circuit & releasing pigtail stopcock, ecmo rns noted air on venous and arterial side of oxygenator of the ecmo circuit.Rn immediately clamped the lines.Code team summoned.Pt bagged and prolonged resuscitation including chest compressions and arrest meds occurred while pt was recannulated and converted to veno arterial ecmo.Pt remained critical and the next afternoon, after lengthy discussion with mds, parent requested that we withdraw treatment.Patient expired while surrounded by family.How air got into the circuit is not known at this time.The tubing remained visually intact & did not "fall apart"; however, it is possible that the stopcock and connectors became loose and allowed air to be drawn into the line.There have been no previous issues with the tubing at this facility.The ecmo machine did not alarm: air was detected by the two ecmo rn's before the air reached the ecmo circuit.Both ecmo rn's had received training/education to perform the line flush and are experienced in this procedure.Preliminary cause of death is ards.Autopsy being performed.

• Brand Name: 30 ML FLUSH MONITORING KIT #3
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 3927487
• MDR Text Key: 4495970
• Report Number: 3927487
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 46010-34
• Device Catalogue Number: 46010-34
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECMO MACHINE
• Patient Outcome(s): Death
• Patient Age: 16 YR
• Patient Weight: 54