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

Model Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in the united states.At the best of livanova knowledge, the following devices are in use at the hospital: 16s10940 (manufactured in 28.03.2007), 16s10939 (manufactured in 27.03.2007), 16s10887 (manufactured in 19.01.2007).A complaints database analysis has been performed and no previous contamination complaints were received from this clinic/devices.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a phone call of a daughter about her father receiving a letter from the hospital about his cardiac surgery some years ago.A heater-cooler system 3t device was used and reportedly the unit was suspected to be contaminated.No further information provided on the potential contamination.The daughter did not report any infection or injury of the father but only that the hospital informed them that the device used during the surgery might have been contaminated.

Manufacturer Narrative

H.10: through further follow-up communication with the perfusionist of the hospital livanova learned that all devices resulted negative to bacterial tests and that a six years retrospective analysis was conducted in order to determine if any patient contracted or died due to mycobacteria infection and the outcome was that no patients resulted to be infected with mycobacterium at the hospital.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9785565
• MDR Text Key: 197124932
• Report Number: 9611109-2020-00157
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1