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

Model Number	101041360
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting including; verifying the user was using correct components; verifying the user was washing parts according to instructions for use; verifying there was no milk backup; and disassembling, inspecting, reassembling kit and tubing.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 our internal investigation (reference number (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 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) 2021, the customer alleged to medela llc that her pump in style max flow breast pump had low suction and was randomly shutting off while in use.She called back later the same day and stated the low suction started today.She indicated she had mastitis and was hospitalized due to it.Her mastitis has been resolved.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on 04/22/2022.It was found during our internal investigation that the customer's pump powered on with the lab transformer and customer's transformer.The device was tested for low suction with a medela lab kit and the customer's kit.There was human milk residue found on the connectors, membranes, pump aggregate (pump motor and pump assembly), and manifold.There was also damage to the pump chassis.The customer's report of low suction could be confirmed.

• 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: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 12413330
• Report Number: 1419937-2021-00072
• Device Sequence Number: 17059271
• Product Code: HGX
• UDI-Device Identifier: 00020451412658
• UDI-Public: 020451412658
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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 Catalogue Number: 101041360
• Device Lot Number: 0000025350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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