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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the adapter plate made a squealing noise.This device is reusable and expired in june 2019.No patient involvement.Product was changed out.Procedure was completed successfully.
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).
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 december 9, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 213, 19, 133) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 19 - cause traced to user investigation conclusions: 133 - end of life problem identified the affected sample was inspected upon receipt with no visual anomalies.The adapter was set on a sorin drive and observed for noises.No abnormal noises were present.It is noted that the device is more than 2 years past its expiration date.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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12971960
• Report Number: 1124841-2021-00274
• Device Sequence Number: 4452575
• Product Code: KFM
• UDI-Device Identifier: 00699753450417
• UDI-Public: (01)00699753450417
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/24/2022

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: 06/30/2019
• Device Model Number: 824043
• Device Catalogue Number: N/A
• Device Lot Number: PK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: S5
• Patient Sex: Unknown