MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN); PUMP, BREAST, POWERED

Model Number	101041360
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including verifying user was using correct kit components; verifying user was washing parts according to instructions for use; verified user was using dry parts when pumping; verifying user was not washing or drying tubing on pump; verified no milk backup occurred; verified the customer disassembled, inspected, cleaned and/or reassembled kit and tubing set; inspected transformer for damage; powered on device with transformer; verified correct breast shield fit.The customer stated she will use her pump in style maxflow pump for 20-30 minutes and get minimal milk output.When she uses her manual harmony pump, she will immediately get a milk let down and up to 5 ounces in the same amount of time.The customer service representative stated there is no visible damage to the pump or condensation in the tubing.She also stated the pumps vibration sounded off at first but then corrected itself.The customer stated her nipples do move in the tunnel of the breast shield, just like they do with the harmony manual pump.The customer service stated she uses the 24mm breast shield sizing.Trouble shooting did not resolve the issue.The customer was sent a replacement pump and return of her original pump and parts were requested for testing/evaluation.In follow up with a complaint handler on 04/20/2023, the customer indicated that she developed mastitis on 03/30/2023 and was prescribed dicloxacillin.The customer stated her mastitis is currently resolved.The device was returned with the customer's parts and accessories and was evaluated on 05/04/2023.The issue of low suction could not be reproduced when tested with the customer kit.The device had low suction when tested with lab kit (connectors and membranes) using customer tubing.No problem found with suction when tested with customer kit (connectors and membranes) using lab tubing.Nothing was visually wrong with the customer tubing.Customer tubing is failing vacuum test with lab and customer kit.Engineering performed a vacuum decay test on the tubing, and it passed.Based on the results of our internal investigation (reference number 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 of mastitis.Riordan & wambach, 4th ed.P.294: breastfeeding and human lactation.However in this case, the mother¿s mastitis required prompt medical attention for pain relief and prescription antibiotics to avoid progression to overwhelming sepsis.
Event or Problem Description
On (b)(6) 2023, the customer alleged to medela llc while using her pump in style with maxflow pump she was experiencing low human milk expression.The customer also alleged she developed mastitis and visited the doctor on (b)(6) 2023 and was prescribed antibiotics.

• Brand Name: PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 16910767
• Report Number: 1419937-2023-00020
• Device Sequence Number: 14989541
• Product Code: HGX
• UDI-Device Identifier: 00020451401447
• UDI-Public: 020451401447
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: 101041360
• Device Lot Number: 0000060496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Distributor Facility Aware Date: 04/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female