MAUDE Adverse Event Report: MEDELA LLC PNSA STARTER BP EN ES USA; PUMP, BREAST, POWERED

Model Number	101035077
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/14/2021
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; disassembling, inspecting, cleaning and reassembling the kit and tubing set; and verifying breast shield fit.Replacement pump accessories were sent to the customer.On 3/18/2021, the customer contacted customer service and stated that the replacement parts did not resolve the suction issue and a replacement device was sent to the customer.In follow up with a complaint handler on 03/23/2021, the customer indicated that she developed mastitis on (b)(6) 2021 and was prescribed an antibiotic.She indicated that the replacement pump was working without issue.(03/23/21 becomes our aware date as we learned the customer was prescribed antibiotics to treat her mastitis.) 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.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) 2021, the customer alleged to medela llc that her pump in style breast pump had low suction.On (b)(6) 2021, the customer called back and alleged that the replacement parts did not resolve the suction issue and she has the pump turned all the way up.Additionally she alleged she has mastitis.In follow up with a complaint handler on 03/23/2021, the customer indicated that she developed mastitis on (b)(6) 2021.(03/23/21 becomes our aware date as we learned the customer was prescribed antibiotics to treat her mastitis.).
Additional Manufacturer Narrative
The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on 08/02/2021 and it passed suction and cycle specifications.The customer's report of low suction could not be confirmed.

• Brand Name: PNSA STARTER BP EN ES USA
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry, il
• MDR Report Key: 11635173
• Report Number: 1419937-2021-00027
• Device Sequence Number: 3356692
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 020451350776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181937
• 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: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 0000013404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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