MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE X-COATED J-LOT; CENTRIFUGAL PUMP

Model Number CV-164275X

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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).

Event Description

It was reported to terumo cardiovascular systems corporation that during a non-clinical activity the packaging of the centrifugal pumpheads was defected.The width of the sterile seal was below specification by.8mm.This occurred during a non-clinical activity; therefore, there was no patient or surgical effect.

• Brand Name: STERILE X-COATED J-LOT
• 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: shari bailey ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5703054
• MDR Text Key: 289194022
• Report Number: 1124841-2016-00126
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 00699753450349
• UDI-Public: (01)00699753450349
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CV-164275X
• Device Lot Number: TD10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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