MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND XTRA EQUIPMENT 110V, 60HZ; APPARATUS, AUTOTRANSFUSION

Device Problems Device Stops Intermittently (1599); Invalid Sensing (2293)

Patient Problem Death (1802)

Event Date 08/21/2017

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided.The date of death was not provided, though it is known that it happened several days after the event date ((b)(6) 2017).Livanova (b)(4) manufactures the xtra equipment.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and found the air sensor to be intermittently showing "air" when liquid was present.The air sensor was replaced to resolve the issue and subsequent functional testing did not identify any further malfunctions.The unit was returned to service.During follow-up communication with the customer, livanova (b)(4) learned that the patient death was not being attributed to the device malfunction by the facility.The perfusionist stated that two xtra cell savers were in the operating room at the time of the event.When the first unit began to experience intermittent problems, the device was switched out without consequence.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The reported event alone is not a reportable malfunction.This report is being filed in response to the patient death, simply as a notification.The customer has reported that no patient issue was caused by the event, and that the death was unrelated to the device.For this reason, any additional investigation results will be documented in the complaint.No further reports will be filed regarding this event.Device not returned.

Event Description

Livanova (b)(4) received a report that the xtra equipment faulted when the user attempted to empty or fill the bowl during procedure to repair an aorta dissection.Though fluid was being emptied or filled at all times, the sensor always read zero and caused the cell savor to intermittently stop emptying or filling every 10 seconds or so.The user switched the unit out with a back-up unit, which allowed them to process the 3000cc of blood in the bowl.The patient reportedly expired several days after the procedure.

• Brand Name: XTRA EQUIPMENT 110V, 60HZ
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6893227
• MDR Text Key: 87320300
• Report Number: 9611109-2017-00755
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 105