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

Model Number	164275
Medical Device Problem Codes	Crack (1135); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, 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.Component code: 925 - pump.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1135 - crack.Investigation findings: 3233 - results pending completion of investigation.
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they noticed a cracked centrifugal disposable pump.No patient involvement.Product was changed out.Procedure completed successfully.
Event or Problem Description
The event was initially reported for a crack in the pump.However, when the actual sample was returned and inspected, it was found that the event was for a foreign matter inside the pump instead of a crack.
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 february 14, 2023.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 1451, 10, 11, 3331, 202, 25).Medical device problem code: 1451 - particulates.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 202 - inappropriate material.Investigation conclusions: 25 - cause traced to manufacturing.The returned sample was inspected upon receipt and confirmed to have a piece of clear plastic inside of the pump that measured out of specification.A retention sample from the same lot number was inspected and confirmed to not have any foreign materials within it.All pumps are 100% visually inspected in process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CENTRIFUGAL PUMP HEADS
• 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: 16371898
• Report Number: 1124841-2023-00047
• Device Sequence Number: 12605087
• Product Code: KFM
• UDI-Device Identifier: 00699753002333
• UDI-Public: (01)00699753002333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 06/30/2025
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: 2H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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