MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TUBE SET STERILE A127 PUMP; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number T0449-01

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Extravasation (1842); Swelling (2091)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that during a procedure the pump began to increase rate of flow with no adjustment having been made to the pressure setting, the patient's shoulder became moderately swollen (extravasated), the pressure was reduced to 20, the pump gradually began to push at an accelerated flow rate again, even with the pressure set at 20.No patient injury reported.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: TUBE SET STERILE A127 PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7537303
• MDR Text Key: 109125804
• Report Number: 3003604053-2018-00079
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: T0449-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1