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 Problems No Patient Involvement (2645); No Information (3190)

Event Date 07/30/2020

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 during setup, the pump head made a small rumble sound.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.

Event Description

New information received that, there was no delay in the procedure, the product was changed out and the surgery was completed successfully with no patient effect.

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 august 19, 2020.  upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem); e1 (initial reporter - updated reporter's name and added phone number); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h6 (event problem and evaluation codes 2645, 11).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).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.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: 10424390
• MDR Text Key: 203479090
• Report Number: 1124841-2020-00194
• 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,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: YA09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• 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