MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU20; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Catalog Number 701010896

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

According to the received information, the hospital doesn't follow the latest instructions by the manufacturer regarding the new cleaning procedure ("new water quality management") that has been introduced with fsca-2017-10-16.The new water quality management is based on the use of trisodium phosphate as cleaning agent.Thus the failure could not be confirmed.The hospital is looking for a solution to get the sterile filtered demineralized water needed to implemented the water quality management procedure.However, the (b)(4) subsidiary ((b)(4)) is currently working with the hospital to help implementing the new water quality management procedure as soon as possible.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.A supplemental medwatch will be submitted after new information has been received.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the results of the bacteriological analysis, the device has been contaminated by a mycobacteria since several months.Besides, according to the latest samples analyzed in (b)(6) 2018, there is also a fungal flora with significant concentration (>150 ufc for 100 ml).Following those latest samples results, the hospital quarantined the device.No clinical consequences were observed.(b)(4).

• Brand Name: MAQUET HCU20
• 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: 7860473
• MDR Text Key: 119938734
• Report Number: 8010762-2018-00255
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701010896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: No
• 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