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 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

The returned purely yours pump was tested per ameda engineering protocol to determine whether the allegation of leaking fluid could be confirmed.It was assessed for indications of malfunction or thermal event.It was also assessed for functionality and met functional specifications.There was very minor evidence (dark grey substance, e.G battery acid) observed inside the battery compartment and on battery cover.Internally, there were no indications of burning, melting or charring visible.

Event Description

Customer contacted ameda, inc.On (b)(6) 2019 regarding an incident that occurred that same day during usage of her purely yours breast pump on battery power.She had installed 6 new (b)(6) alkaline batteries in the pump base after forgetting her ac adapter at home that day.Customer states hearing a hissing noise coming from the base at the end of the pumping session.She stopped pumping, opened the battery compartment and noted dark fluid covering the batteries.One battery was damaged and leaking fluid.Customer reports no burn or injury since she waited until fluid cooled before removing batteries from base.Customer was shipped a replacement purely yours breast pump after this event.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day dr.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 8562852
• MDR Text Key: 147322816
• Report Number: 3009974348-2019-00339
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 0081072501477
• UDI-Public: (01)0081072501477(21)
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/29/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• 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: 36 YR