MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HYST. FLUID MGMT SYSTEM CONTROL UNIT; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number 7210164

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 10/08/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation was not possible, as the device is not being returned.A review of the device history records and quality records associated with this manufactured lot/serial number confirmed that no additional complaints have been filed.A review of the service records confirmed that this unit has not been returned for service.No further investigation is warranted at this time.(b)(4).

Event Description

It was reported that during a procedure that there was a recorded deficit to the patient of 3200 + normal saline.No adverse outcome to patient.Case was completed with pump and patient discharged.(b)(4).

• Brand Name: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5010191
• MDR Text Key: 23248847
• Report Number: 1643264-2015-00117
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210164
• Device Lot Number: 1403CM620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention