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

Model Number 3ZZ164275X

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp that during cardiopulmonary bypass approximately 50 cc of blood leaked from the pump head around the seal perimeter.Fifty cc of blood loss.Product was not changed out.Procedure was completed successfully without delay.

Manufacturer Narrative

Terumo has received the actual 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 more information becomes available.(b)(4).

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 to the fda on 04/28/2015.Visual inspection of the actual sample revealed crazing around the top housing weld.A small crack was found on the top housing underneath the outlet port, as well as two 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 and ran for one hour.The sample did not leak.The test was repeated using a 10 percent bleach and water solution with no back pressure.The sample began to leak after 30 minutes.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.Eight retention samples from the same product code were visually inspected and no anomalies were noted.A review of the device history record revealed no anomalies.The part was subjected to a 100 percent in process leak test prior to packaging.The sample was likely damaged after packaging causing it to leak.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 SYSTEM 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: 4742669
• MDR Text Key: 5706934
• Report Number: 1124841-2015-00110
• 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,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 3ZZ164275X
• Device Lot Number: TA26
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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