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

Model Number HEATER-COOLER UNIT

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet is developing new hygiene protocols for its heater-cooler units hcu 40, hcu 30 and hcu 20.These new protocols include preventive measures, routine disinfection as well as high level disinfection and biofilm reduction  also effective against atypical mycobacteria in the water systems.The newly developed disinfection procedures are taking a holistic approach based on validated methods.The timeline for the introduction of the new hygiene protocols is being examined in order to communicate reliable dates as requested by health authorities.A supplemental medwatch will be submitted when new information has been received.

Event Description

It was reported that the hcu40 was contaminated with mycobacteria.The water samples were taken during service, so there was no patient involved or could be harmed.(b)(4).

Manufacturer Narrative

On (b)(6) 2017 12:06 pm (gmt-4:00) added by (b)(6).On (b)(6) 2015, the fsca (b)(6) 2015 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)(6) 2015.A new fsca will be issued as soon as the new disinfection procedure is properly validated and can be launched.As part of the fsca, the instruction for use (ifu) was to be revised with a new disinfection procedure.This revised procedure was due to be implemented by december 2016.It was verified that this procedural update was completed on (b)(6) 2016.

Event Description

(b)(4).

Manufacturer Narrative

On (b)(6) 2017 10:12 am (gmt-4:00) added by (b)(6): for the reported issue, the question was asked if the guidance, which was provided to the customers, should be reviewed as air samples obtained confirmed the presence of mycobacterium.(b)(6), head of regulatory affairs, responded in an email (dated (b)(6) 2017) to this question as follows: "apparently mycobacteria were found in the tank water, that's why the incident should be reported.During de-airing, the mycobacteria were also detected on the fuel cap, which is possible.However, de-airing is never performed during an open heart operation with a patient with an open chest.Therefore the only known transmission pathway for mycobacteria from hcus to the heart is thus excluded in this case; there is no risk of infection." it is understood that the hcu40 device is not defined as a sterile device.The use of normal tap water, when operating the hcu40 device, always have the potential for bacterial growth, however, it has been confirmed previously that during use, there is no risk of contamination to the patient.The reported contamination issue was observed during cleaning which normally occur outside of the operating theatre with no patient involvement.Also as stated in the response by (b)(6), this contamination is observed during de-airing of the device which is part of the cleaning process.Thus the revised cleaning process is not impacted by this reported issue.

Event Description

Internal reference: (b)(4).Customer ref.: (b)(6).

• Brand Name: MAQUET HCU40
• 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: 6526041
• MDR Text Key: 74042258
• Report Number: 8010762-2017-00133
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER-COOLER UNIT
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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