MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. BULK NON STER XCOAT DELPH PUMP; CENTRIFUGAL PUMP

Model Number 3ZZ164275X

Device Problem Infusion or Flow Problem (2964)

Patient Problem Injury (2348)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass procedure, there was an issue with the forward flow of the circuit.As per sales representative, the perfusionist initiated hand cranking then changed the circuit.*product was changed out.*delay of approximately 2 minutes.*blood loss over 200 ml.*surgery was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on february 6, 2017.(b)(4).A visual inspection was performed on the returned sample upon receipt.No anomalies were noted anywhere on the device.A review of the device history record revealed no manufacturing anomalies.The returned pump was circulated at 2000 and 3000 rpm's while varying backpressure.Pressure readings were taken at 2, 4, 6, and 7 l/min flow rates.There were no anomalies with the component's functionality.The flow rates were compared to the ifu flow rate graph and were comparable and approximately the same.A retention sample from the sample product family/lot was obtained.The unit was circulated at 2000 and 3000 rpm's while varying backpressure.Pressure readings were taken at 2, 4, 6, and 7 l/min flow rates.There were no anomalies with the component's functionality.The flow rates were compared to the ifu flow rate graph and were comparable and approximately the same.The results from the retention sample were comparable to the complaint samples.There was no flow issues noted with the pump complaint sample or retention sample.The reported event was not able to be recreated; therefore, the complaint was not confirmed and a definitive root cause was not able to be determined.It is possible that the pump had not been properly set up on the drive motor, causing forward flow to stop.Through communication with the customer contact, it is believed that the cause of the event is due to perfusionist error, and it is not believed that there are any functional issue with the terumo devices.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: BULK NON STER XCOAT DELPH PUMP
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6305411
• MDR Text Key: 66630974
• Report Number: 1124841-2017-00014
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112229
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: UM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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