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

Model Number 824043

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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, the centrifugal pump adapter is not holding the head in properly.As per the user facility, it was held firmly by hand for the entire case by a second assistant, and used unit until replacement is received.No known impact or consequence 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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 28, 2020.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information) h6 (identification of evaluation codes 4114, 3221, 4315) method code: 4114 - device not returned results code: 3221 - no findings available conclusions code: 4315 - cause not established the sample was not returned; therefore, a thorough investigation could not be performed and a definitive root cause could not be determined.Retention samples are not kept for this product line.Adapters are 100% tested prior to release including pump interface testing.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: 10331642
• MDR Text Key: 200602469
• Report Number: 1124841-2020-00171
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 824043
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1