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 01/31/2018

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.Dark grey substance, e.G battery acid, was observed inside the battery compartment.Internally, no signs of foreign substance, burning, melting or charring were observed.The returned batteries were observably damaged.The battery fluid crust was observed on returned batteries.Additional testing confirmed that batteries may leak when the up battery is placed incorrectly, with the positive and negative end reversed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2018 to report pumping on the morning of (b)(6) 2018 using battery power.She explained this was the first time using batteries inside the battery compartment.The ac adapter was not plugged into the pump base at the time.Customer states the pump began to slow down so she replaced the 6 aa batteries with new batteries.Customer noted dark fluid leaking from the battery compartment of the pump base after using the new batteries.She did not come in contact with the fluid and reports no injury or burn.Customer was overnight shipped a replacement purely yours breast pump base.

• 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 ; 8479642620
• MDR Report Key: 7304757
• MDR Text Key: 101576514
• Report Number: 3009974348-2018-00309
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725021477
• UDI-Public: (01)00810725021477(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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/31/2018

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: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2017
• 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