MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 DAY TUBE SET (3); ARTHROSCOPE

Model Number	7211007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cassette started to leak into the pump which has also caused damage to the d25.No patient injury reported.The procedure was completed with a device from another company.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.Tube set evaluation revealed that transducer membranes were missing from the cassette.The complaint was confirmed and a root cause has been associated with a manufacturing error.

• Brand Name: DYONICS 25 DAY TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7307802
• Report Number: 1643264-2018-00186
• Device Sequence Number: 1656068
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: (01)03596010543608(17)200930(10)50688195
• Combination Product (Y/N): N
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 7211007
• Device Catalogue Number: 7211007
• Device Lot Number: 50688195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1