MAUDE Adverse Event Report: BALLOON PUMP

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Device Output (2953)

Patient Problems Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 06/20/2013

Event Type  Other  

Event Description

Balloon pump incorrectly installed by untrained pa causing blood flow to lower body to be cut off.This led to the amputation of right foot and decreased blood flow to left leg and foot.

• Brand Name: BALLOON PUMP
• Type of Device: BALLOON PUMP
• MDR Report Key: 6124736
• MDR Text Key: 60876885
• Report Number: MW5066283
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; CARVEDILO; FUROSEMIDE; LISINOPRIL; PACE RONE; PANTOPPRAZOLE; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 83