MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PUMP A127 GOFLO; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	A127
Health Effect - Clinical Code	Swelling (2091)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a halfway into case the surgeon noticed that the patients operative shoulder was beginning to swell due to extravasation.He requested to his assistant to reduce the pressure ( was running on 40mmhg), assistant reduced the pressure to 30mmhg.Extravasation continued rapidly, surgeon removed the trocar and cannula from the patient with fluid still running, fluid flow was extremely fast out of trocar at 300mmhg.The surgeon requested the pump to be stopped and returned to the hospitals typical fluid pump system ( linvatec 10k).
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.
Additional Manufacturer Narrative
An evaluation was performed by the supplier and could not confirm the customer complaint for the patients operative shoulder was beginning to swell due to extravasation.A visual inspection was performed and showed there were no indications of damage or misuse.Functional inspection was performed and indicated the returned device passed all criteria.This included a pressure test with a result of pass.No manufacturing related defects were observed.

• Brand Name: PUMP A127 GOFLO
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7547394
• Report Number: 3003604053-2018-00080
• Device Sequence Number: 167697
• Product Code: FEQ
• UDI-Device Identifier: 04056702003715
• UDI-Public: (01)04056702003715
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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 Model Number: A127
• Device Catalogue Number: 72204968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/27/2018; 11/28/2018
• Initial Report FDA Received Date: 05/28/2018
• Supplement Report FDA Received Date: 07/31/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1