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	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including inspecting the faceplate and back plate for damage; inspecting and cleaning the diaphragm; and disassembling, inspecting, cleaning and reassembling the kit and tubing set.It was identified during troubleshooting that the customer had replaced all her parts, but continued to have low suction on the left side and strong suction on the right side.The troubleshooting did not resolve the issue.The customer was sent a replacement faceplate, but refused to return her original faceplate for testing/evaluation.The customer contacted customer service again on 04/29/2019, and alleged that the replacement faceplate did not correct the issue.She additionally alleged that she still had mastitis and was going back to see her doctor.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.(b)(4).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 on the left side.She additionally alleged that she had mastitis and was prescribed antibiotics, but did not think the mastitis was due to the pump.
Additional Manufacturer Narrative
The device was returned with the customer's parts and accessories and was evaluated on (b)(6)2019.The device passed suction and cycle specifications when tested with the customer's 24 mm one-piece breast shields.The device was then retested using the customer's personal fit connectors and 24 mm personal fit breast shields and did not pass suction and cycle specifications; therefore, it was evaluated with a medela lab kit and it passed suction and cycle specifications.Refer to attached product evaluation and pictures.When a pump fails with the customer kit, but not the lab kit, any issue is typically attributable to the kit, not the pump.In this case, it was noted in the evaluation that the customer's personal fit connectors and valves 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 customer's report of low suction was confirmed when using her personal fit connectors and 24 mm personal fit breast shields.

• 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: 8585781
• Report Number: 1419937-2019-00073
• Device Sequence Number: 1731706
• Product Code: HGX
• UDI-Device Identifier: 00020451570631
• UDI-Public: 00020451570631
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 450330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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