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

Model Number 3ZZ164275X

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the 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 when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the pump head had air entering around the seal.*no patient involvement, *product was changed out, *surgery was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 21, 2017.Upon further investigation of the reported event, the following information is new and/or changed: the returned sample was visually inspected, during which dried blood could be seen around the weld.Upon evaluation of the returned sample, the pump was found to not pull air into the circuit during circulation testing.When a vacuum was pulled directly from the pump outlet, air could be seen coming from the back housing into the circuit.This same effect occurred while testing the retention sample.As the pump did not pull air into the circuit during normal use, it is likely that a vacuum was pulled onto the pump causing air to enter the circuit from the back housing of the pump.The specifications in the ifu do not indicate that the centrifugal pump should operate at any negative pressures.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: 6580814
• MDR Text Key: 75603586
• Report Number: 1124841-2017-00090
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: UN15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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