MAUDE Adverse Event Report: AMEDA, INC. PURELY YOURS ULTRA; ELECTRIC BREAST PUMP

Model Number 24501879

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The returned product was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed.The returned product was assessed for indications of malfunction or thermal event.The returned product was assessed for functionality and met functional specifications.Crusted battery fluid was observed inside the battery compartment, inside of housing and on the side of pump motor.Internally, no signs of foreign substance, burning, melting or charring were observed.Because the batteries were not returned, engineering cannot confirm if a battery placed in the pump leaked.Additional testing supports that the misplacement of a battery can case battery leakage.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report that while pumping with the purely yours ultra breast pump, she heard a pop sound from the battery compartment.Black fluid began leaking from the battery compartment,.Customer removed the compartment door which resulted in the fluid flowing out onto the hands of the user.She states no injury, burn or property damage.She washed her hands after disposing of batteries.Customer admitted to using the pump using batteries and ac adapter simultaneously.At the time of this event, she was only using 6 aa batteries.

• Brand Name: PURELY YOURS ULTRA
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 5521209
• MDR Text Key: 41027072
• Report Number: 3009974348-2016-00201
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24501879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR