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 08/03/2016

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 pump contained damaged batteries.The middle battery on top of the row of batteries was installed backwards.The battery fluid leakage was caused from the misplacement of the middle battery.

Event Description

Customer contacted ameda, inc.On (b)(6) 2016 to report an incident while pumping this morning using batteries to power on her purely yours breast pump.She states hearing a loud pop from inside the pump base during pumping and the pump stopped functioning.Customer looked inside the battery compartment and found several batteries exploded, having emptied black fluid inside the compartment.She reports no contact with this fluid and it stayed confined to the battery compartment.She denies injury, burn or property damage.A replacement purely yours pump base has been sent to customer to resolve this issue.

• 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: 5919405
• MDR Text Key: 53637467
• Report Number: 3009974348-2015-00215
• 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: 08/03/2016

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: 24502082
• 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: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2015
• 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: 24 YR