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

Model Number 16-02-85

Device Problem No Apparent Adverse Event (3189)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation in order to clarify the reported event.Based on available information there is no evidence that the device cause or contributed to the reported event.In addition on the reported event there is no evidence on any possible or potential device malfunction and there is no allegation of any device malfunction other than product being used during procedure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a medwatch report mw#(b)(4) about a patient fainted 3 times in (b)(6) 2017 on different days.The patient also had significant fatigue and shortness of breath.In (b)(6) 2018 the patient began to have diarrea, vomiting and stomach pain and presented to the hospital.The patient was discharged home with zofran.One week later patient's vomiting persisted and re-presented to the hospital where an echo was performed and was found to have severe dilatated cardiomyopathy and a calculous cystitis.Serial echo demonstrating poor cardiac output and the patient was ultimately listed as needing heart transplant.An lvad was required due to his rapid decompensation along with intubation.Within the report preexisting characteristics that may have contributed to the event are listed: coronary heart desease, allergies to povidone iodine, shellfish allergy, measles mumps and rubella virus vaccine live, varicella virus vaccine live.In the report the event date is (b)(6) 2018 with no specific day and for this reason the data of event is not filled out.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9626513
• MDR Text Key: 188403784
• Report Number: 9611109-2020-00033
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2019
• Date Device Manufactured: 12/10/2014
• 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