MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACKS

Model Number 65410

Device Problem No Flow (2991)

Patient Problem Blood Loss (2597)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation is in progress, conclusion not yet available.The actual device has been returned.The sample has been decontaminated but not yet evaluated by the supplier.At this time the complaint cannot be confirmed.There was no indication as to where the hemoconcentrator was inserted in the cpb circuit.The device history record (edhr) was reviewed for any anomalies, there were no issues noted.Additionally our supplier has provided initial evaluation of their device history record and release documentation and there were no indications of production related anomalies, or nonconforming inspections.All available information has been place on file in quality management for appropriate tracking, trending and follow-up.The case level gtin for this pack is (b)(4).The production identifiers are (b)(4).

Event Description

The customer reported that the hemoconcentrator had no flow during cardiopulmonary bypass (cpb).It was replaced with a second hemoconcentrator and the same issue was encountered.There was blood loss as a result of the no flow situation, the first unit loss 20ml of blood while the second unit lost 80ml.It is unknown as to whether or not the patient required any blood transfusions.There was no delay to the procedure and product was changed out.The surgery was completed successfully.

Manufacturer Narrative

The sample was received by the supplier and upon receipt it was visually inspected, there was no obvious anomaly such as a fiber break noted.The sample was then rinsed, dried, and again subjected to another visual inspection, there were no anomalies such a fiber break or clog in the fiber noted.The sample was then built into a circuit with tubing, where bovine blood (ht25%@37c) was circulated through the sample.The blood was confirmed to flow all the way through the sample with no issues.The blood was circulated at a flow rate of 500ml/min and tmp400mmhg, although a pressure drop was noted it was determined to be within specification.No clogging was observed.Based on the evaluation of the supplier, the actual sample was verified to be the normal product, presenting no clogging in the fiber.Therefore, the customer's complaint was not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACKS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 28 howe street; ashland MA 01721
• Manufacturer Contact: jean burns ; 28 howe street; ashland, MA 01721 ; 5082312417
• MDR Report Key: 6362626
• MDR Text Key: 68464975
• Report Number: 1212122-2017-00002
• 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,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 65410
• Device Lot Number: UL19
• Other Device ID Number: (01)50699753458432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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