MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL PUMP ADAPTER

Model Number	824043
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
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 loud noise came from the revolution pump when the delphian pump was attached and was running at 1900 rpm.No consequences or impact to patient.Product was not changed out.Procedure was completed successfully.
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 november 15, 2018.Upon further investigation of the reported event, the following information is new and/or changed: d1 (suspected medical device - corrected brand name).D4 (additional device information - corrected model number, lot number & udi number).D10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and correction).H3 (device evaluated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusion 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.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.Visual inspection was performed on the sample upon receipt, during which no anomalies were noted anywhere on the device.The sample was built into a saline circuit and then set up on a sorin drive motor.The rpm were set at 900 and ramped up by 300 rpm every ten minutes for one hour for a maximum of 2400 rpm.During each interval, the returned sample was observed for any running sound anomalies.No sound anomalies were observed during the evaluation a retention sample was obtained and tested the same way, no sound anomalies were noted.The returned sample was found to not make any sound anomalies during setup or when hand cranked on the motor.The reported issue was not able to be replicated; therefore, a root cause was not able to be determined.It is possible that the pump adapter or pump was set up incorrectly, causing the devices to make noise during setup or use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Hold - 07/07 - t.O.
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 november 15, 2018.Upon further investigation of the reported event, the following information is new and/or changed: d1 (suspected medical device - corrected brand name).D4 (additional device information - corrected model number, lot number & udi number).D10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and correction).H3 (device evaluated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusion code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SARNS CENTRIFUGAL PUMP ADAPTER
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8074860
• Report Number: 1124841-2018-00292
• Device Sequence Number: 2363824
• Product Code: KFM
• UDI-Device Identifier: 00699753450417
• UDI-Public: (01)00699753450417
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/07/2019

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 Expiration Date: 08/31/2022
• Device Model Number: 824043
• Device Catalogue Number: N/A
• Device Lot Number: TL21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 02/06/2019; 07/06/2023; 07/06/2023
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 07/06/2023; 12/20/2018; 02/07/2019
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown