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

Model Number	101034712
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was sent a freestyle flex breast pump due to her issues with the freestyle pumps and return of the replacement freestyle pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2020, the customer confirmed that she had finished her course of antibiotics and that the freestyle flex breast pump was working without issue.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 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 via email that she had another instance of mastitis when using the replacement freestyle breast pump she received as a result of the incident reported in medwatch 1419937-2020-00057.She alleged that her right breast was producing less milk due to the faulty pump and requested that a freestyle flex breast pump be sent to her, which her lactation specialist advised.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on (b)(6) 2020.It was noted that the customer's kit was assembled incorrectly and had residue on the parts.The pump was first tested with the customer kit as it was assembled when received and failed the suction and cycle specifications.The parts were reassembled the correct way and tested again and the pump failed the suction and cycle specifications.The pump was tested a third time with a medela kit and it passed all suction and cycle specifications.Refer to attached evaluation.The customer's report of low suction was plausible due to the incorrect assembly of parts along with noted residue on parts.

• 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: 10298570
• Report Number: 1419937-2020-00068
• Device Sequence Number: 2780233
• 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: 08/21/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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