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

Model Number	75974
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was not returned.No sample was received for evaluation but a picture was provided confirming the reported issue.Device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed for this component and the component was deemed conforming by the supplier surge cardiovascular.100 percent pull testing was performed by the supplier to a specification of 5 lbs and all product passed this specification, there were no failures reported by the supplier.Additionally there were no issues noted in the review of the incoming inspection records.This complaint is being reviewed internally and with the supplier of the product surge cardiovascular.The results of this investigation will be updated in the follow-up mdr.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.The case label gtin: (b)(4).The product identifier: (b)(6).
Event or Problem Description
The customer reported that during a cardiopulmonary bypass (cpb) procedure, the tip of the sucker came off in the patient's chest.It happened 1 to 1.5 hours into the case and was noticed right away when it fell off.The tip was removed and the product was changed out.The surgery was completed successfully.There was no patient injury or blood loss.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the initial report submitted november 12, 2018.(b)(4).The supplier conducted a root cause analysis and found the root cause was due to insufficient glue.Our supplier has since automated the glue dispensing process and validated this new process which controls time, pressure and vacuum of the glue application.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• 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: 8033773
• Report Number: 1212122-2018-00020
• Device Sequence Number: 19158137
• Product Code: OEZ
• UDI-Device Identifier: 00699753506268
• UDI-Public: (01)00699753506268
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/18/2018

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: 06/30/2020
• Device Model Number: 75974
• Device Lot Number: WH23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1