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

Model Number 3ZZ164275X

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp that during cardiopulmonary bypass the centrifugal pump head leaked.Blood loss of 60 ml over three and a half hours.Product was not changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has not yet received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is complete and more info becomes available.(b)(4).

Manufacturer Narrative

This f/u report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on may 4, 2015.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 f/u report is submitted to fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems.Upon evaluation of the device, the complaint was confirmed.Initial visual inspection of the actual sample revealed crazing around the top and bottom housing welds.A small crack was found on the top housing underneath the outlet port, as well as multiple cracks on the top housing near the weld.The actual sample was setup on a sarns drive motor and built into a circuit of saline solution.The rpm was set to 3500 rpm with a back pressure of 660mmhg.The sample began leaking after approximately 10 minutes of testing.The leak was coming from the cracks in the top housing located at the top housing / separator weld underneath the outlet port of the pump.The crack was caused by dehp compound residue on the x-coated separator of the pump.The separator came into contact with dehp when it was dipped into the incorrect tank during manufacture.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 CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, quality mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4752285
• MDR Text Key: 5827556
• Report Number: 1124841-2015-00125
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ZZ164275X
• Device Lot Number: TC03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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