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

Model Number 3ZZ164275X

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that out of box, the centrifugal pumps from the cardiovascular procedure kits were cut out (6 pumps were cut out of 6 kits).The user facility did not want to use lot ta08 due to previous pump leak complaints.No patient involvement as this occurred out of box.Product was not used.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has not received the actual 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 more information becomes available.For this reason, terumo referenced evaluation conclusion.

Manufacturer Narrative

This f/u report is submitted to fda in accord with applicable regulations, and as indicated by terumo cardiovascular system in the initial report submitted to the fda on june 2, 2015.A second f/u will be submitted upon completion of the investigation and/or submission of new info.All available info has been placed on file in quality management for appropriate tracking, trending and f/u.

• Brand Name: BULK NON STER XCOAT DELPH PUMP
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; 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: 4818376
• MDR Text Key: 5897617
• Report Number: 1124841-2015-00177
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• 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: TA08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MD-2015-003-R
• Patient Sequence Number: 1