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

Model Number	58200
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including disassembling, inspecting, cleaning and reassembling the kit and tubing set.Following troubleshooting, the customer indicated that the issue was not resolved.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2019, the customer confirmed that she developed mastitis on (b)(6) 2019, that the replacement pump was working without issue and that the mastitis was resolved.The customer requested contact from a medela clinician, who provided the customer with tips to help prevent clogged ducts and mastitis.The device was returned with the customer's parts and accessories and was evaluated on 08/02/2019 and it failed suction/cycle specifications.It was identified during the product evaluation that the spare parts and breast shields were dirty and the tubing was broken.After cleaning the parts, the device was retested and passed suction and cycle specifications.Refer to attached evaluation.The customer's report of low suction was confirmed.Any foreign contaminants that hinder the device's ability to form an adequate vacuum seal could potentially result in lower suction.It is very difficult to determine exactly how much contamination under normal use is needed for pump vacuum to suffer, but it is a known failure mode causing low suction.The sonata instructions for use details cleaning procedure for the parts and accessories.It is also a common troubleshooting item to check.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4)% for the period of january 2013 to august 2017.Mastitis is usually a benign, self-limiting infection with few consequences for the suckling infant.The risk of mastitis is higher among women who have breastfed previously, especially those with a history or mastitis." riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.Mastitis requires prompt medical attention for the mother for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2019, the customer alleged to medela llc that after pumping with her sonata breast pump, she felt as if she still had milk to pump from her breasts, as it did not seem as if the pump was emptying all of the milk.She purchased new parts in an attempt to resolve the issue, but it did not help.She further alleged that she had mastitis, for which she was prescribed antibiotics.

• Brand Name: SONATA DELUXE SINGLE PACK
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 8897412
• Report Number: 1419937-2019-00103
• Device Sequence Number: 19185682
• Product Code: HGX
• UDI-Device Identifier: 00020451582009
• UDI-Public: 00020451582009
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 58200
• Device Catalogue Number: 58200
• Device Lot Number: 444516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/15/2019
• 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