MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Catalog Number 701044054

Device Problem Contamination (1120)

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

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to laboratory tests the hcu40 was positively tested for mycobacteria.Thus the failure could be confirmed.As mentioned in the instruction for use, the device has to be cleaned with a 5% chloramine-t concentration in the entire water volume of the hcu 40 for special, highly effective disinfection and biofilm removal.The chloramine-t solution must be allowed to act for 24 hours.As stated by email, laboratory tests, performed one month after, came back clean for this device.This reported incident was identified as an issue relating to the decontamination procedures for the device.Capa (b)(4) was opened to address the reported issue.A health hazard evaluation (hhe) was performed to determine the risk associated with the reported issue and the outcome was determined to be low.However, fsca 2015-11-30 was initiated to address the cleaning and decontamination process within the ifu of the hcu40 device.This procedural update was completed on 29 november 2016.

Event Description

It was stated that the hcu40 was positively tested for mycobacteria.No patient injury/harm reported.(b)(4).

• Brand Name: MAQUET HCU 40
• 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: 7209722
• MDR Text Key: 98052839
• Report Number: 8010762-2018-00030
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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