MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701028718

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 03/23/2015

Event Type  malfunction  

Manufacturer Narrative

Feb.29, 2016 10:47 am (gmt-5:00) added by (b)(6): (b)(4).A maquet field service technician was on site and tested the unit 4 hours.He was unable to duplicate the error code.The technician verified that the unit reached and maintained the temperature at 4, 20, 31 and 40.5 degrees.Functional tests were performed and it was verified that the unit was calibrated to factory specifications and safety inspected.(b)(4).

Event Description

Feb.29, 2016 10:24 am (gmt-5:00) added by (b)(6): it was reported the device shutdown while on a patient with error code l004-2.Unit was re-started and continued to support patient for rest of case.No patient effect reported.(b)(4).This is a duplicate of mfg report # 8010762-2015-00379.This medwatch is being generated per fda correspondence received february 29,2016 that requires a supplemental /follow-up medwatch be filed electronically.

• Brand Name: MAQUET HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5467477
• MDR Text Key: 39596540
• Report Number: 8010762-2016-00126
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2015

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: 701028718
• Device Catalogue Number: 701028718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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