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

Model Number 701044054

Device Problem Contamination (1120)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).On (b)(4) 2015, fsca (b)(4) was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet.This fsca was put on hold a few days later with fsca (b)(4).A new fsca will be issued as soon as the new disinfection procedure is properly validated and can be launched.The new ifu is currently under revision and will contain the instructions for the new disinfection procedure; (b)(6) 2016 is the scheduled market launch for this new disinfection procedure.A supplemental medwatch will be submitted if additional informations becomes available.

Event Description

It was reported that in the first set of water samples isolated environmental mycobacteria and pseudomonas were found.Following the 2nd sanitisation and subsequent waters samples, results were negative for pseudomonas.(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): 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: 5594646
• MDR Text Key: 44148443
• Report Number: 8010762-2016-00284
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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