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

Model Number 24502082

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/26/2017

Event Type  malfunction  

Manufacturer Narrative

The returned product was tested per ameda engineering process 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.Dark grey substance, e.G battery acid crust , was observed inside the battery compartment.The battery fluid crust was observed on battery compartment door.Additional testing confirmed that batteries may leak when the upper middle battery is placed incorrectly, with the positive and negative end reversed.Additional testing supports that the misplacement of a battery can cause battery leakage.

Event Description

Customer contacted ameda, inc.On (b)(6) 2017 stating she was using the purely yours breast pump on battery power when a recent incident occurred.She stated using the same 6 aa batteries for the past 20 pumping sessions when her pump stopped functioning properly on (b)(6) 2017.This event prompted customer to look at the batteries inside the battery compartment.She noted the batteries were corroded with white dust covering them.Customer reports she kept these batteries inside the pump base at the same time she used the ac adapter to power on her pump.Customer states she was unaware of any batteries leaking acid and did not hear anything unusual during her previous pumping sessions.

• Brand Name: PURELY YOURS
• 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 ; 8479622620
• MDR Report Key: 6508953
• MDR Text Key: 73462444
• Report Number: 3009974348-2017-00261
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• 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: 34 YR