MAUDE Adverse Event Report: LIVANOVA DUTSCHLAND GMBH HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The device has not been used with a patient.The water quality monitoring and h2o2 concentration check is performed as per ifu everyday.The device is cleaned regularly as per the ifu.The tanks are not emptied if device not used and testing conducted daily including weekend.The device is placed outside of the operation theatre during use if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about an heater cooler not passing the cleaning/bacteria control.No report of any patient involvement.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DUTSCHLAND GMBH; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DUTSCHLAND GMBH; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10407894
• MDR Text Key: 204028194
• Report Number: 9611109-2020-00466
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1