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

Model Number 3ZZ164275X

Device Problems Image Display Error/Artifact (1304); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 08/24/2015

Event Type  malfunction  

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).Conclusions: conclusion not yet available - evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during prime, they experienced an overspeed message from the system 1 while using the centrifugal pump.The pump head was unattached and reattached, and there was still no flow from the pump.No patient involvement as this occurred during prime.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 system in the initial report submitted to the fda on september 17, 2015.(b)(4).Upon evaluation of the device, the complaint was not confirmed.The actual sample was visually inspected upon receipt, finding no anomalies.The sample was circulated at 2000 and 3000 rpm's while varying the back pressure.Pressure readings were taken at 2, 4, 6, and 7l/min flow rates.A centrifugal pump retention sample was taken from lot tg13 and the test was repeated.No anomalies were noted with either sample.A review of the device history record revealed no anomalies.A definitive root cause could not be determined.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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5084915
• MDR Text Key: 26111106
• Report Number: 1124841-2015-00255
• 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 Health Care Professional
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 3ZZ164275X
• Device Lot Number: TG13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 MO
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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