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

Model Number 70104.4054

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 02:34 pm (gmt-4:00) added by (b)(6) ((b)(4)): maquet cardiopulmonary have not yet received any lab results which confirm the bacterial contamination.This issue is under further investigation with regard to capa (b)(4).A supplemental medwatch will be submitted as soon as additional information becomes available.(b)(4).

Event Description

(b)(6) hospital have had some water samples analysed from the hcu's (2x 40's and 1x 30) and have had a positive result for mycobacterium from one of the samples.They have not as far as we are aware tested the tap water but have now added a bacterial water filter to the tap used to fill the heater coolers.Further samples are away for culture at the moment.They have been following the ifu to the letter up to this point and this sample was taken just before the scheduled cleaning process.

Manufacturer Narrative

(b)(4).Further information has not been forthcoming from the customer.A questionnaire was sent to the customer on 2015-07-23.They have not completed the form or specified which of the two hcu40s were the source of the results.The have at present not released any lab findings.No decontamination report was provided for this unit.On 2015-11-30, a fsca was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet.Since the issuance of the 2015-11-30 fsca, maquet has become aware of the possibility that the rinsing process for the high level disinfection with 5% chloramine-t may not adequately remove all residual disinfectant.Therefore maquet is putting the 2015-11-30 fsca on hold pending a resolution of this issue.In order to ensure the highest possible patient safety, maquet has decided to perform a further validation to ensure safety factors are challenged by the disinfection processes delineated in the corresponding ifus.This additional validation will challenge the disinfection process with real world, highly contaminated devices representing the worst case possible.This validation will be performed and completed: in january 2016 for hcu 40.In february 2016 for hcu 30 & hu 35.In march 2016 for hcu 20.A supplemental medwatch will be submitted as soon as additional information are available.

Event Description

No patient injuries have been connected with this report.(b)(4).

Manufacturer Narrative

On nov 30,2015, fsca 2015-11-30 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 2015-12-10.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.Market launch of the new disinfection procedure is december 2016.

Event Description

(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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5019226
• MDR Text Key: 24660006
• Report Number: 8010762-2015-01006
• 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: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• 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