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

Model Number 76234

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

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.The reported issue was not confirmed as there was no sample or photos received from the customer.The device history record was reviewed and there were no assembly issues noted with line 14a or line 22.The incoming raw material documentation was reviewed for the tubing and the connector and there were no discrepancies noted.This was a customer made connection and as stated per our ifu under the instructions for use section 7 ¿inspect all connections for leaks of any kind, fluid or gas, from the inside the circuit to outside, or vice versa.Tie band and tighten all connections in the circuit.Push tubing past the second barb for the user made connections.¿ the customer did state the connection was made to the first barb and tie banded.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).No sample or photographs were received.

Event Description

The customer reported that the tubing got disconnected at quarter inch connector located at line 14a (a customer made connection) on pack spec during cardiopulmonary bypass surgery, resulting in approximately 300cc blood loss.The product was not changed out, they reconnected the tubing.There was no delay and 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 Contact: erica mcnamara ; 28 howe street; ashland, MA 01721 ; 5082312454
• MDR Report Key: 7432345
• MDR Text Key: 106024287
• Report Number: 1212122-2018-00003
• Device Sequence Number: 1
• Product Code: OEZ
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 76234
• Device Lot Number: WA08
• Other Device ID Number: (01)00699753504554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2018
• 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