MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70104.4054

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

October 21, 2015 12:03 pm (gmt-4:00) added by (b)(6): (b)(4).A maquet field service technician was on site and investigated the unit in question.The technician checked the cardioplegia circuit and the ice formation.After troubleshooting the device, the technician could confirm the reported issue with the low flow because the ice block forming setup on the cardioplegia side was set too high.The setup for the ice formation was set to 2/3 which caused the problem with the low flow.The technician cleaned the unit and changed the water.Functionality tests were performed successfully.A supplemental medwatch will be submitted as soon as additional information becomes available.

Event Description

It was reported that the flow on the cardioplegia side of a hcu40 device is too low.The device was exchanged immediately.No patient involvement (b)(4).

• Brand Name: MAQUET HCU40 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5166820
• MDR Text Key: 28906052
• Report Number: 8010762-2015-01119
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.4054
• Device Catalogue Number: 70104.4054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Patient Outcome(s): Required Intervention