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 08/04/2016

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.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.Additional testing confirmed that batteries may leak when the upper middle battery is placed incorrectly, with the positive and negative end reversed.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report pumping on the evening of (b)(6) 2016 with the purely yours ultra breast pump.She states replacing the 6 aa batteries inside the battery compartment prior to pumping.During the pumping session, she heard a loud pop sound coming from the base of the pump.Customer stopped pumping, opened the battery compartment and found leaking black fluid inside.She states the batteries appeared intact.Customer wiped out the black fluid and did not use the pump from this time on.A replacement purely yours ultra breast pump was shipped to the customer.Customer denies coming in contact with this black fluid.No injury or burn was reported.

• 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: 5919416
• MDR Text Key: 53663694
• Report Number: 3009974348-2015-00216
• 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: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• 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: 08/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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: 25 YR