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

Model Number	CV-164275X
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1124841-2016-00126
• Device Sequence Number: 15059849
• Product Code: KFM
• UDI-Device Identifier: 00699753450349
• UDI-Public: (01)00699753450349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: 03/08/2016
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 06/07/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown