MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CENTRIFUGAL PUMP HEADS

Model Number	164275
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemolysis (1886); Injury (2348); Blood Loss (2597)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a hemolysis of blood was found in the centrifugal pump head.As per user facility, their setting was around 1000 to 150 revolutions per minute (rpm).No abnormal sound was heard on the centrifugal drive motor during procedure and was advised that they are still using the system 1 with the roller pump as the primary pump.No known impact or consequence to patient.There was a delay for approximately 20 minutes.The product was changed out.The procedure was completed successfully.It is unknown if there was a blood loss.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.  method code: 4114 - device not returned.Results code: 114 - operational problem identified.Conclusions code: 19 - cause traced to user.The actual sample was not returned for evaluation, and a thorough investigation could not be performed.The lot number was not provided; therefore, a retention sample could not be evaluated.The picture that was provided confirmed the event, possible root cause that could explain the observed failure mode are, clamping of the outlet port with the pump running, inadequate heparinization of the patient, extended use past the rated duration of 6 hours, and lack of a suitable recirculation line.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information was obtained from the user facility that the blood loss was around 800 cc.Per clinical review; approximately an hour into a cardiopulmonary bypass procedure the user facility team experienced what was considered a blood hemolysis event due to the centrifugal pump and the centrifugal drive motor.A photo was provided showing that it depicts a coagulation occurrence, and has been restated as such from the end user - a thrombus.Per user facility the only information regarding the coagulation measurements and heparin management made available was that at some time during the procedure the act was 459 seconds.The end-user also add that the drive motor and the disposable were both hot to the touch.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: (identification of event problem and evaluation codes 2348, 2597, 11).A third follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on april 03, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (corrected describe event or problem).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to correction).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references (b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
As per user facility, their setting was around 1000 to 1500 revolutions per minute (rpm).

• Brand Name: CENTRIFUGAL PUMP HEADS
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8480345
• Report Number: 1124841-2019-00089
• Device Sequence Number: 1062790
• Product Code: KFM
• UDI-Device Identifier: 00699753002333
• UDI-Public: (01)00699753002333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 04/21/2019; 05/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/03/2019; 05/09/2019; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other