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

Model Number B72736-02

Device Problems Misconnection (1399); Device Operational Issue (2914)

Patient Problem Blood Loss (2597)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) was reviewed and there were no issues related to the 3/8¿x1/4¿x3/8¿ y component or the assembly of line #13.The sample was received, decontaminated and assessed.The sample had two tie bands on the ¼ port and a portion of tubing from another manufacturer¿s pack.This was a user made connection.The tie-bands and tubing were removed from the returned sample and through visual inspection it was noted there was no damage or deformation to the ¼¿ port.Next the first and second barb were measured, and the dimensions were found to be within specification.It was also learned during the investigation that the initial connection was not tie-banded.The two tie-bands were added when the line was reconnected.Per terumo cardiovascular procedure kit ifu precautions ¿6) pushing user made connections past the second barb and tie-banding all user made connections will prevent disconnection and leaks.¿ terumo does not manufacturer or distribute the quest microplegia.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).

Event Description

The customer reported that during cardiopulmonary bypass (cpb), a tubing (from another manufacturer's device) disconnected from 3/8" x 3/8" x 1/4" "y" connector.This was a user made connection.The disconnection resulted in approximately 750cc blood loss.The product was not changed out.The surgery was completed successfully.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• Manufacturer (Section G): SAME
• Manufacturer Contact: erica mcnamara ; 28 howe street; ashland, MA 01721 ; 5082312454
• MDR Report Key: 7604861
• MDR Text Key: 111155399
• Report Number: 1212122-2018-00007
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00699753497184
• UDI-Public: (01)00699753497184
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: B72736-02
• Device Lot Number: WC12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• 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
• Treatment: QUEST MICROPLEGIA