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

Model Number 7210164

Device Problem Output below Specifications (3004)

Patient Problem No Code Available (3191)

Event Date 12/29/2014

Event Type  Injury  

Event Description

During an operative hysteroscopy to treat a 2cm fibroid using a hysteroscopic fluid management system, it was reported that the patient was retaining fluid.Although the pressure was set on 90 and the intrauterine pressure was 70, the pump was pumping faster than normal.There was an inflow of 5,300 mls and a deficit of 3,100 mls.The patient was given lasix and since it produced a minimum output of fluid, the patient was taken back to the operating room to have the excess fluid removed.The surgeon performed a culdocentesis and drained 4,300 mls of fluid.There was no perforation of the uterus.The patient¿s post-operative condition was reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.No further investigation is warranted at this time.A review of the device history record was performed which confirmed no inconsistencies.(b)(4).

• Brand Name: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• Type of Device: HYST. FLUID MGMT SYSTEM CONTROL UNIT
• 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: 4452530
• MDR Text Key: 5395092
• Report Number: 1643264-2015-00004
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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): Hospitalization; Required Intervention