MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT

Model Number	75911
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue reported was not confirmed since no sample or sample photographs were received.Therefore, no definite root cause could be determined.The device history record (dhr) was reviewed and no issues were noted for the connector, or thermistor as well as, assembly and layering of line #2.The sterilization load records were reviewed and upon receipt of the load, there was no load damage noted.Additionally, the shipping records for this product were reviewed and there was no shipping damage noted upon receipt.Raw material inspection records and certificates of conformance (coc) were reviewed for these components and the components were deemed confirming.Unkown if the connection was tightened prior to use as per the cardiovascular procedure kit ifu.All available information has been placed on the file in the quality management for appropriate tracking, trending, and follow-up.(b)(4) device not made available by end user.
Event or Problem Description
The customer reported at the end of a cardiopulmonary bypass (cpb) procedure, while transferring the cardioplegia mixture of blood and crystalloid to the cell saver the temp well was dislodged and fell out of the connector luer port.This resulted in an approximate 30 milliliters (ml) loss of mixed cardioplegia consisting of blood and crystalloid.The product was not changed out.The line was clamped and the transfer stopped.Additionally, no cardioplegia was being administered.The surgical procedure was completed successfully.There was no delay nor adverse consequences to the patient.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 11066698
• Report Number: 1212122-2020-00005
• Device Sequence Number: 2974878
• Product Code: OEZ
• UDI-Device Identifier: 50699753501855
• UDI-Public: (01)50699753501855
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 02/28/2022
• Device Model Number: 75911
• Device Lot Number: Y20930210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1