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 09/29/2016

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 functioned at low suction.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 the pump base of the purely yours ultra breast pump became hot and batteries began leaking black sticky fluid while pumping on (b)(6) 2016.She was not using the ac adapter with batteries installed in the battery compartment.She states coming in contact with the black leaking fluid but denies burn or injury.

• 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: 6063514
• MDR Text Key: 58771267
• Report Number: 3009974348-2016-00230
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 10/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2015
• 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: 36 YR