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

Model Number 3ZZ164275X

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2020

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 setup, there was air in the pumphead.No patient involvement; product was changed out; procedure 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 november 23, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 3259, 4210, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code #1: 3259 - improper physical structure.Results code #2: 4210 - leakage/seal.Conclusions code: 4307 - cause traced to component failure.The affected sample was inspected upon receipt with no visual anomalies.The pump was then filled with water and pressurized where it was observed that water leaked into the back housing.A vacuum was pulled on the pump to confirm air bubbles entering the pump between the seal rotor and stator.This confirms a thin crack between the seal rotor and stator.A representative retention sample from the same product code and lot number was filled with water and pressurized with no leakage observed.A vacuum was then pulled on the pump to -150mmhg where no air entered the pump.All centrifugal pumps are visually inspected in process and 100% leak tested at the final leak tester prior to packaging.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
• MDR Report Key: 10890680
• MDR Text Key: 218253355
• Report Number: 1124841-2020-00268
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: YC21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1