MAUDE Adverse Event Report: MEDELA AG FREESTYLE BREAST PUMP - SINGLE; PUMP, BREAST, POWERED

Model Number	101034712
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent detailed troubleshooting tips and breast shield sizing guidance in an emailed response on (b)(6) 2020.In follow up with a complaint handler on (b)(6) 2020, the customer indicated that the troubleshooting tips had not resolved her suction issue and she believed it was an issue with the rubber membrane in her spare parts.She additionally indicated that she had been diagnosed with mastitis on (b)(6) 2020, and had been prescribed an antibiotic, but it was now resolved.She was offered and declined contact with a medela clinician since she had already been in contact with a lactation specialist who helped her rent a medela symphony pump, but stated she wanted to return the freestyle breast pump and receive a different medela pump.The complaint handler advised the customer to contact medela customer service regarding the return and replacement of her freestyle breast pump.On (b)(6) 2020, the customer called in to medela customer service and during troubleshooting she indicated it was the rubber membrane that wasn't working properly, but later insisted it was the pump and not the spare parts causing low suction.She indicated that she wanted to use her pump in style breast pump parts with the freestyle pump, but the customer service representative explained that would not work.She was offered a pump in style breast pump as an exchange, which the customer declined.On (b)(6) 2020, the customer again called into medela customer service and was sent a medela sonata breast pump.Return of her original pump was requested for testing/evaluation.On (b)(6) 2020, the customer was contacted by the complaint handler in writing to confirm whether the sonata pump was working for her and to check on the return of her original pump, with no response as of the date of this report.Based on the results of ca11-001, 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) 2020, the customer alleged via email to medela llc that her freestyle breast pump was losing suction during every pumping session, causing her to have to disconnect and reattach all of the spare parts to regain suction.She additionally alleged that she was disappointed in the pump and felt that it contributed to her recent mastitis.She requested a return, exchange, or to receive consolation since it was an inconvenience to her and her exclusively bottle-fed baby.
Additional Manufacturer Narrative
The device was evaluated on (b)(6) 2020 with the customer's parts as received and it failed vacuum testing.The vacuum test was then conducted using a lab kit with the customer's pump and it passed.A third vacuum test was then conducted with the customer's parts assembled correctly and it passed.Refer to attached product evaluation.When a pump fails with the customer kit, but not the lab kit, any issue is typically attributable to the kit, not the pump.In this case, it was noted in the evaluation that the customer's connectors and membranes were not assembled correctly.

• Brand Name: FREESTYLE BREAST PUMP - SINGLE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug,
• MDR Report Key: 9942732
• Report Number: 1419937-2020-00033
• Device Sequence Number: 2094169
• Product Code: HGX
• UDI-Device Identifier: 00020451330921
• UDI-Public: 020451330921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150499
• 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

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: 101034712
• Device Catalogue Number: 101034712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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