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 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

The returned purely yours breast pump was assessed for functionality and met functional specifications.There was no internal evidence to support the allegation of a pump malfunction or thermal event.Evidence supports that the misplacement of a battery in the battery compartment resulted in battery failure/leakage.

Event Description

Customer contacted ameda, inc.On (b)(6) 2019 to report the ameda ac adapter prong broke off where it inserts into the electrical outlet.She was speaking with the ameda parent care representative to report this event.She was instructed to install 6 new aa alkalne batteries into the battery compartment of the purely yours pump base to test pump on battery power.She could then operate the pump on batteries as she waited for the shipment of a replacement ac adapter.While pumping on battery power, user reported the pump suddenly stopped operating and she heard a hissing sound from inside the pump base.Customer looked inside the battery compartment to find some batteries leaking dark fluid.The fluid stayed confined to the compartment.She denied any burn or injury when this event occurred.Customer was overnight shipped a replacement ac adapter and 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: 8378328
• MDR Text Key: 138134806
• Report Number: 3009974348-2019-00337
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/19/2019

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: 02/26/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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: 29 YR