MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION( TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	75635-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned.It was stated that the part was discarded.There was no sample, photograph or product lot number received and as a result, no product or device history record evaluation could be performed.The customer confirmed it was a user made connection.Per the manufacturer's instructions for use (ifu), to ensure a proper connection the clicking sound must be heard when the two parts come together and thumb press must be completely closed.And also the white thumb press must return to its original state.Otherwise, under pressure and certain force the parts will come apart.This can not be confirmed since there was no sample to evaluate.The root cause of the reported issue cannot be determined.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.(b)(4).
Event or Problem Description
The customer reported that during cardiopulmonary bypass (cpb), the customer made connection of the quick connector line l3.It resulted in approximately 300-500 milliliters (ml) of blood loss and a 30 seconds delay to the procedure.The product was not changed out as they reconnected the line.The surgical procedure was completed successfully.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION(; 28 howe street; ashland MA 01721
• MDR Report Key: 9368493
• Report Number: 1212122-2019-00011
• Device Sequence Number: 2286969
• Product Code: OEZ
• UDI-Device Identifier: 00699753499881
• UDI-Public: (01)00699753499881
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/25/2019

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 Model Number: 75635-01
• 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: 11/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1