MAUDE Adverse Event Report: MEDELA LLC SONATA DELUXE SINGLE PACK; PUMP, BREAST, POWERED

Model Number	58200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Troubleshooting was conducted with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set and verifying correct breast shield fit.During troubleshooting, the customer did not see any damage to the parts and indicated that she washes according to the instructions.A replacement pump was sent to the customer and return of the original pump was requested.In follow up with a complaint handler on (b)(6) 2018 regarding return of the pump, the customer indicated that she had to return the replacement pump due to the charger not fitting properly, so she was going to continue to use her original pump, which she was able to use if single pumping.Additionally, on (b)(6) 2018, the customer alleged that she had clogged ducts, which her doctor believed was due to the pump.After repeated attempts to follow up regarding the report of clogged ducts, the customer finally responded on (b)(6) 2018 that she did get a clogged duct while using the pump, but felt it was from a combination of an oversupply and her son having breathing issues.The customer indicated that she was prescribed a nipple ointment to help open her nipple, but the clog continues to come and go and her next step will be to visit a dermatologist.In further follow up with the complaint handler on (b)(6) 2018, the customer indicated that her clogged duct was 99% gone, but she was still a little sore.The customer also indicated that she had received the second replacement pump and would try it at a later date.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2018, the customer alleged to medela (b)(4) that her sonata breast pump had low suction with an air leak alert, had a loud noise coming from the housing, and the display was difficult to read.
Additional Manufacturer Narrative
The device was returned without the customer's parts and accessories; therefore, it was tested with a medela lab kit on (b)(6)2019.Though the device displayed an air leak alert and repeatedly failed suction and cycle specifications in single pumping mode at minimum expression setting for pattern 2, the unit passed with the same settings for pattern 1, and additionally passed suction and cycle specifications for eleven other setting configurations between patterns 1 and 2.The difference between pattern 1 and pattern 2 is a slight change in shape of the vacuum wave, but the vacuum rate is identical between the two patterns.Though the customer's report of low suction and an air leak alert was confirmed, the anomaly observed during evaluation of this device is believed to be an isolated incident which does not require additional investigation.

• Brand Name: SONATA DELUXE SINGLE PACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry 60050
• MDR Report Key: 7792728
• Report Number: 1419937-2018-00183
• Device Sequence Number: 1573733
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: 00020451582009
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K161725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 58200
• Device Catalogue Number: 58200
• Device Lot Number: 439907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other