MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. NPWT PICO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problems Thermal Decomposition of Device (1071); Disconnection (1171); Hole In Material (1293); Temperature Problem (3022)

Patient Problem Confusion/ Disorientation (2553)

Event Date 05/07/2013

Event Type  Injury  

Event Description

A confused patient was wearing a pico and when the nurse entered the room she smelled burned plastic.The patient had by himself disconnected the dressing and the pico while in the bed.The pico was very warm and a hole was in the front of the device.

Manufacturer Narrative

The returned pump has been comprehensively analysed by a 3rd party assessment company and evidence of urine contamination within the battery compartment was confirmed.The contamination left deposits on the molex connector within this area (that connects the batteries to the circuit board), which in turn created an electrical short, leading to the issues seen on the returned pump.The findings of the investigation have therefore confirmed that the failure has occurred due to product misuse.

• Brand Name: NPWT PICO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr.; st. petersburg, FL 33716
• MDR Report Key: 4890245
• MDR Text Key: 6071568
• Report Number: 8043484-2015-00201
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K111170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2013

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2013
• Initial Date FDA Received: 07/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention