MAUDE Adverse Event Report: MEDELA LLC PNSA PUMP STARTER 1CT PT-A EN ES; PUMP, BREAST, POWERED

Model Number	101035077
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 the customer alleged to medela llc that her pump in style advanced breast pump would not turn on or suction correctly, which had caused her to go to the hospital where she was diagnosed with mastitis and prescribed antibiotics.
Additional Manufacturer Narrative
Customer service conducted troubleshooting with the customer, including attempting to power on the breast pump with the customer's transformer and battery pack, but the customer did not have the battery pack with her.The troubleshooting did not resolve the issue and it was noted the breast pump was a replacement from a previous case and the customer was out of warranty.A replacement device was not sent to the customer, but return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on 02/24/22, the customer indicated she had returned her breast pump and inquired if we would repair and return it to her.The complaint handler explained to her the breast pump would not be repaired, but would be evaluated and disposed of.The customer replied in a second email and expressed her disappointment in our warranty policy, which was forwarded to our customer service team for them to document it as a voice of the customer entry.The device was returned without the customer's parts and accessories and was evaluated on 03/08/2022.It was determined during the evaluation that the motor on the pump was detached from the gearbox.The customer¿s report of power issues was confirmed.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 (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 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.

• Brand Name: PNSA PUMP STARTER 1CT PT-A EN ES
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 13711377
• Report Number: 1419937-2022-00024
• Device Sequence Number: 6373670
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 020451350776
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 03/09/2022

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: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 0000022601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Distributor Facility Aware Date: 02/18/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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