MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BULK NON-STERILE DELPHIN PUMP; CENTRIFUGAL PUMP

Model Number 3ZZ164275

Device Problem Decoupling (1145)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2016

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.For this reason, terumo references evaluation conclusion code.(b)(4).Conclusions code: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, the pumphead decoupled.The pump was changed out and it decoupled again.The motor was then changed out and it seemed to work.No patient involvement as this occurred during set up.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 july 15, 2016.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.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 the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted.The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected, and no anomalies were noted that would relate to the reported issue of decoupling.The sample was then set up on a sarns drive motor and the rpm was set at intervals of 500 rpm until a maximum of 3500 rpm was reached.The sample stayed connected to the drive motor without any signs of decoupling.While running at each interval, the pump was rotated while seated in the drive motor to ensure it would not decouple.The pump continued functioning as intended without disconnecting from the drive motor; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: BULK NON-STERILE DELPHIN PUMP
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5798258
• MDR Text Key: 49656202
• Report Number: 1124841-2016-00278
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 3ZZ164275
• Device Catalogue Number: N/A
• Device Lot Number: UC22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1