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

Model Number 71381-04

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/02/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 - line 9a between drip chamber and l14 leaked blood.On (b)(6) 2014 - the customer further reported that the bubble trap came apart during the cardioplegia delivery.The leak occurred at the drip chamber and approximately 1 liter of fluid was lost (800cc of blood, 200cc of crystalloid cardioplegia).This did not result in the pt receiving a blood transfusion and the product was not changed out, but held together by the profusionist.

Manufacturer Narrative

On (b)(6) 2014, terumo was informed that the original report of 5cc's of blood loss was incorrect and the fluid loss was approximately 1000cc's.The customer stated that the connection between the bubble trap and tubing had to be held together to complete the surgery.There was no transfusion as a result of the blood loss.Terumo did not receive the actual device but did receive a photograph of the leaking part and did obtain three remaining samples of the same pack 71381-04 and lot qc18r from inventory and evaluated for strength at the connection via instron pulls and other samples were challenged by over-pressurization testing.The issue as described by the customer was not replicated.Complaint will be included in associates awareness training.The device history did not indicate any production related problems.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.(b)(4).

• Brand Name: CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe st.; ashland MA 01721
• Manufacturer Contact: jean burns, manager ; 28 howe st.; ashland, MA 01721 ; 5082312417
• MDR Report Key: 3667188
• MDR Text Key: 4197849
• Report Number: 1212122-2014-00001
• Device Sequence Number: 1
• Product Code: GAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 71381-04
• Device Lot Number: QC18R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2013
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention