MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO CDI 500 BLODO PARAMETER MONITOR

Model Number 500AHCT

Device Problems Thermal Decomposition of Device (1071); Power Conditioning Problem (1474)

Patient Problem Death (1802)

Event Type  Death  

Event Description

It was reported that during use of the device for a extracorporeal membrane oxygenation (ecmo) procedure, the blood parameter monitor (bpm) appeared burnt.The device was not changed out.Refer to the clinical review for further information.Per the clinical review on(b)(6)2015: a (b)(6) neonatal pt was placed on ecmo shortly after birth for cardiac and respiratory support.According to the perfusionist (ccp), the pt was very sick, and at high risk.During the early hours of the morning, the ccp stated there were three power surges in the intensive care room where the ecmo support was being provided.The first surge did not appear to have any impact on any of the equipment or devices used on this pt.The second power surge caused the bpm display to flash, with lines running through the display and a continuous and muted audible tone was observed coming from the bpm.In a very few seconds the display blanked and there was a "burning smell" that appeared to be coming from the bpm monitor.The ccp very quickly disconnected the bpm power cord from the alternating current (a/c) outlet.In a short time, a third power surge occurred and this surge lead to the stopping of the ecmo perfusion pump (not the manufacturer's device).This halted all cardiac and respiratory support.The pt deteriorated, due to loss of cardiac and respiratory support, and the pt expired.The ccp stated that the loss of the bpm unit played no part in the death of the pt.The sudden loss of the pump, which stopped ecmo support, did have an impact on this very ill pt.The bpm unit was not changed out, as the third power surge (with loss of pump capacity) occurred before a replacement bpm unit was available.The ecmo procedure was not completed as planned, and the pt expired.The bpm issue did not delay the procedure and did not lead to associated blood loss.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.No other manufacturer product were being used per clinical services.

• Brand Name: TERUMO CDI 500 BLODO PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4652212
• MDR Text Key: 18091437
• Report Number: 1828100-2015-00265
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ECMO PERFUSION PUMP
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 3 DA