MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number	57063
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The customer responded on (b)(6) 2019 that she would return the original pump the week of (b)(6) 2019; however, no additional information was provided by the customer, including how the replacement pump was working for her and whether the mastitis was resolved.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) 2019, the customer alleged to medela llc that her pump in style breast pump had low suction.The customer further alleged that she was diagnosed with mastitis, for which she started treatment.
Additional Manufacturer Narrative
The device was evaluated on 10/02/2019 with the customer's parts as received.Four (4) vacuum tests were performed with the customer's parts and, though the results of all four (4) tests were within vacuum/cycle specifications, the results were lower than when the pump was tested off of the production line.A fifth (5th) vacuum test was conducted using a lab kit with the customer's pump and the results were within vacuum/cycle specification and increased over the first four (4) tests.Refer to attached product evaluation and pictures.It was noted in the evaluation that the customer's membranes had residue on them.Any foreign contaminants that hinder the device's ability to form an adequate vacuum seal could potentially result in lower suction.It is very difficult to determine exactly how much contamination under normal use is needed for pump vacuum to suffer, but it is a known failure mode causing low suction.The pump in style instructions for use details cleaning procedure for the parts and accessories.It is also a common troubleshooting item to check.The customers report of low suction is plausible.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 9130157
• Report Number: 1419937-2019-00123
• Device Sequence Number: 3642624
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: 00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K031614
• 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: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 451509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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