MAUDE Adverse Event Report: MEDELA AG FREESTYLE W TOTE PT-A 1CT EN; PUMP, BREAST, POWERED

Model Number	101034712
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/07/2020
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 troubleshooting did not resolve the issue.The customer was sent a replacement pump and return of her original pump was requested for testing/evaluation.The customer was contacted by a complaint handler on multiple occasions, including in writing, to get additional information, with no response as of the date of this report.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 0.008% 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 to medela llc that she was experiencing low suction with her freestyle breast pump, even on the maximum vacuum setting.She additionally alleged that she was developing mastitis, for which she was prescribed antibiotics.
Additional Manufacturer Narrative
The device was evaluated on 09/17/2020 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 also failed.The customer's report of low suction was confirmed.It was identified in the evaluation that there was damage on the membrane plate on the motor aggregate (refer to attached picture and product evaluation), which confirms the customer's report of low suction; however, ca11-001 found that it cannot be definitively concluded that a low vacuum breast pump causes or contributes to mastitis.

• Brand Name: FREESTYLE W TOTE PT-A 1CT EN
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341,
• MDR Report Key: 10108390
• Report Number: 1419937-2020-00052
• Device Sequence Number: 14337641
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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