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

Model Number 3ZZ164275X

Device Problem Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2020

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 prime, the centrifugal pump made a rattling noise.As per the sales associate, the higher the rpm, the louder the noise.It has noisy internal fin after priming.No patient involvement.The 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 september 8, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 170, 23).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: 170 manufacturing process problem identified.Conclusions code: 23 manufacturing deficiency.The affected sample was inspected upon receipt with no visual anomalies noted.The unit was setup in a saline circuit with a sarn drive system and the pump exhibited no unusual noises.However, when setup on the sorin drive with a terumo cp adapter, an audible noise was observed.A representative retention sample was tested as well with no visual or sound anomalies.Based on this investigation, it is believed that the root cause of this failure mode is a combination of a poor technique in using the arbor press for applying the bearing to the rotor and the dimension of the bearing pocket in the magnet housing.A capa has been initiated to document and address the investigation and any potential changes required to remedy the failure mode observed.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: 10501622
• MDR Text Key: 206119189
• Report Number: 1124841-2020-00210
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: YA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1