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

Catalog Number 72204968

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Date 08/30/2018

Event Type  malfunction  

Event Description

It was reported that during rotation cuff repair, pump was set at 30mmhg but shoulder became very distended and hard.Doctor feels pump pressure was greater than 30mmhg.Pump and tubing were exchanged.There was no significant delay or patient injuries.

Manufacturer Narrative

An evaluation was performed by the supplier and could not confirm the customer complaint for the pump pressure is greater than 30mmhg.Visual inspection was performed and showed the pump is in good general condition.The upper casing is scratched, the tube set holder paint coat is chipped, and the hand wheel is missing.Function inspection 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
• Type of Device: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7873859
• MDR Text Key: 120395462
• Report Number: 3003604053-2018-00145
• Device Sequence Number: 1
• Product Code: FEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204968
• Device Lot Number: 72204968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1