MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	60-03-75
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.The device worked according the specification.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a centrifugal pump console stopped measuring the pressure and an error message was displayed during procedure.There was no report of patient injury.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 8729955
• Report Number: 9611109-2019-00471
• Device Sequence Number: 2572224
• Product Code: KFM
• UDI-Device Identifier: 04033817901020
• UDI-Public: (01)04033817901020(11)180920
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K020571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-03-75
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1