MAUDE Adverse Event Report: SYMBIOS GOPUMP RAPID RECOVERY SYSTEM; ELASTOMERIC PUMP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Overdose (1988); Tinnitus (2103); Palpitations (2467); Shaking/Tremors (2515)

Event Date 12/14/2010

Event Type  Injury  

Event Description

The symbios gopump rapid recovery system was used for my auxiliary node dissection surgery.The surgeon place the double chamber pump with flow rate of 6ml/hr during the surgery.I am a (b)(6) female, lean body mass.I was sent home the same day, and by evening was feeling extremely shaky and was experiencing heart palpitations and ringing in my ears.During the early morning hours, my husband and i called the help number on the pump brochure we were given to see what to do.The hotline person advised me to clamp off the pump hose to stop the flow of marcaine anesthesia until i could see doctor in the morning.First thing next morning, the nurse at the surgeon office pulled out the tube delivering the anesthesia.The extreme shakiness and heart palps got better as the marcaine slowly wore off, however, my ears have never recovered.I believe it was too much delivered into my system by the pump and poor placement of the tube as well.Update to present, i have had issues in range of motion to that arm and shoulder and worry that the medication delivered by the pump damaged other bone and vessels in that area.This is the first i saw of the pump recall, and am not surprised.I kept my brochure on it because i felt it caused me these problems and i am thankful i had the pump clamped off as soon as i did due to the heart palps or in think it could have been fatal.

• Brand Name: GOPUMP RAPID RECOVERY SYSTEM
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): SYMBIOS
• MDR Report Key: 4964778
• MDR Text Key: 15356042
• Report Number: MW5045040
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: MARCAINE
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 50