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

Model Number	76477
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is anticipated but not yet begun.Photographs of the sample have been received.The sample has also been received but not yet decontaminated.Device history record was reviewed and no issues were noted related to this complaint.The cardiovascular convenience kit had been in use for four days.It was used in a manner inconsistent with product labeling "this product is indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours, and then discarded in a manner which is within applicable law(s) and practices".All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).
Event or Problem Description
It was reported that the cardiovascular convenience kit was being utilized for extracorporeal membrane oxygenation (ecmo).On the fourth day of usage, during a transfusion of platelets, line 1, l0 (a customer specified pressure line) on the arterial line (post oxygenator) broke.It resulted in approximately 100 ml blood loss.The line was changed out resulting in a short delay in the therapy.The patient was indicated as okay.
Additional Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corp.In the initial report submitted august 31, 2018.Upon further investigation of this reported event, the following information is new and/or changed: date received by manufacturer; indication that this is a follow-up report; follow-up due to device evaluation; indicates device evaluated; identification of evaluation codes.Methods: 10 - testing of actual/suspected device; results: 140 - wear problem; conclusions: 18 - failure to follow instructions.The sample was decontaminated was then visually inspected.A jagged break along 90% of the tubing circumference, located next to the male adapter on line 1 segment l0 was observed.Additionally, there was a syringe and a needle adapter attached to the stopcock at the end of the line.This caused the line to hang at a sharp angle from the male adapter, also contributing to the failure was the constant vibration of the pump and line usage.The jagged edge at the break is indicative of over-usage.It was reported the cardiovascular procedure kit was in use for 4 days prior to the line break.As per cardiovascular procedure kit labeling, the kit is indicated for "use for periods up to 6 hours".All available information has been placed on file in the quality management system 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: 7837714
• Report Number: 1212122-2018-00015
• Device Sequence Number: 1189270
• Product Code: OEZ
• UDI-Device Identifier: 00699753506183
• UDI-Public: (01)00699753506183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/02/2018

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: 09/30/2019
• Device Model Number: 76477
• Device Lot Number: WA08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1