MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL PUMP ADAPTER

Model Number 824043

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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, after 1-2 minutes, a grinding noise form the centrifugal pump was observed.No consequences or impact to patient.Product was not changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The actual sample was visually inspected upon receipt with no anomalies noted anywhere on the device.The sample was built into a saline and set up on a sorin drive motor.The rpm (revolutions per minute) were set at 900 and ramped up by 300 rpm every ten minutes for an hour for a maximum of 2400 rpm.No sound anomalies were observed during the evaluation.A retention sample was obtained and tested the same way, no sound anomalies noted.The actual sample was found to not make any sound anomalies during setup or when hand cranked on the motor.It was not able to be replicated; therefore, a root cause was not able to be determined.It is possible that the pump adapter or pump was set up incorrectly, causing the devices to make noise during setup or use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 december 21, 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SARNS CENTRIFUGAL PUMP ADAPTER
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8191901
• MDR Text Key: 131333767
• Report Number: 1124841-2018-00342
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 00699753450417
• UDI-Public: (01)00699753450417
• Combination Product (y/n): N
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 824043
• Device Catalogue Number: N/A
• Device Lot Number: PG25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1