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	04/28/2020
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.After troubleshooting, the customer indicated that the suction was restored and the issue was determined to be a kit cleaning/assembly issue.On (b)(6) 2020, the customer called back and alleged that the pump was once again producing low suction, indicating that the suction on the right side was lower than the left, but both sides were low.A replacement device was sent to the customer and return of her original pump was requested for testing/analysis.The customer was contacted by a complaint handler on multiple occasions, to get additional information, with no response as of the date of this report.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) 2020, the customer alleged to medela llc that her pump in style breast pump had low suction.She additionally alleged that she had mastitis in the past and was prescribed an antibiotic.
Additional Manufacturer Narrative
The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on (b)(6) 2020 and four (4) vacuum tests were performed using the lab kit and it passed suction and cycle specifications in all four (4) tests.Refer to attached product evaluation.The customer's report of low suction could not be confirmed.Attachment: [case-2020-00290706+product+evaluation.Pdf].

• 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: 10038098
• Report Number: 1419937-2020-00041
• Device Sequence Number: 14199762
• Product Code: HGX
• UDI-Device Identifier: 07612367007566
• UDI-Public: 7612367007566
• Combination Product (Y/N): N
• 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: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 456507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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