MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM

Model Number 809810

Device Problems Insufficient Cooling (1130); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the heater cooler unit would not cool.There was a delay in the middle cardioplegia (cpg) delivery of about ten to twelve minutes.The customer turned the unit on high flush, switched the two sides, but did not help the issue.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2015: during the second dose of blood cardioplegia, the unit did not cool the cardioplegia solution to the desired temperature level.According to the perfusionist (ccp), the low water level light emitting diode (led) illuminated, even though the water level appeared to be adequate.The dose of cpg was stopped and a second water device (cincinnati sub zero unit) was brought into the operating room (o/r) and used for the cpg circuit.The second dose of cpg was completed once the additional water system was ready.According to the ccp, this delayed the procedure by about ten minutes.The heater cooler unit continued to be used for the oxygenator water supply.According to the ccp, the case was completed successfully without associated blood loss.The patient was weaned from cpb in normal fashion and there was no harm observed.

Manufacturer Narrative

The reported complaint was not verifiable.The customer canceled the service call.The perfusionist (ccp) discovered there was a blockage in the tank causing the problem.After the blockage removed the unit ran properly.The unit was not returned to the mfr for eval.No add'l action will be taken at this time.

• Brand Name: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: HX2 TEMPERATURE MANAGEMENT SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4597325
• MDR Text Key: 21326451
• Report Number: 1828100-2015-00141
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 809810
• Device Catalogue Number: 809810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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