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

Model Number 101035077

Device Problem Increase in Suction (1604)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Tachycardia (2095)

Event Date 03/02/2019

Event Type  Injury  

Manufacturer Narrative

The customer requested that customer service have a supervisor contact her, which the supervisor did on (b)(6) 2019.The customer was sent a freestyle breast pump and return of her original pump in style pump was requested for testing/evaluation.In follow up with a complaint handler on 03/19/2019, the customer indicated that soreness began around (b)(6) 2019 and the mastitis developed overnight on (b)(6) 2019.She additionally indicated she had a developing injury on the edge of her breast where it made contact with the breast shield, along with soreness and pink coloration developing bilaterally on the nipples and areolas.The customer was offered and refused contact by a medela clinician because she is receiving care from a lactation consultant team in the nicu where her babies are staying.On the same day, in further follow up with the complaint handler, the customer indicated she had just finished her last antibiotic dose and was following up with her doctor on (b)(6) 2019.She indicated that the freestyle pump was working well, even though it had not emptied her well the first couple of times she used it.In additional follow up with a complaint handler on (b)(6) 2019, the customer confirmed that the mastitis was now resolved.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.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 Description

On (b)(6) 2019, the customer alleged to medela llc that the suction on her pump in style breast pump had increased to the point where it was at maximum suction, even when on the lowest vacuum setting.The customer stated that she did not realize there was an issue until it became gradually painful; she had even taken her pump to a lactation consultant, who assumed the pump was working fine and had her change breast shield sizes.The new breast shields did not help and the pump kept progressively damaging her breast tissue, which led her to suspect that there was an issue with the pump, so she took it back to the lactation consultant.The lactation consultant tested the vacuum level of the breast pump and found it was at maximum vacuum level, even at the lowest setting.The customer additionally alleged that the damage to her breast tissue allowed an infection to set in and she ended up being hospitalized for mastitis resulting in sepsis, with a fever of 104.7 and a heart rate in the 160 range.She was prescribed several antibiotics to fight the infection, ended up with galactoceles blocking her milk flow and leading to mastitis on the other side, and was still on antibiotics as an outpatient to cover what was left of the infection.

Manufacturer Narrative

The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit and it failed high vacuum specifications.The vacuum test was then conducted using a lab pc board with the customer's pump and it passed; thus, isolating the issue to the customer's pc board that connects to the pump potentiometer.The device was further analyzed by quality engineering on 05/17/2019 and the customer's complaint of high suction was confirmed.During their evaluation, they identified a failed potentiometer.This issue is currently being investigated under capa: 0002030; additionally, a scar, which is in effectiveness, has been initiated with the supplier.

• Brand Name: PNSA STARTER BP EN ES USA
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• MDR Report Key: 8472710
• MDR Text Key: 140593612
• Report Number: 1419937-2019-00054
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00020451350776
• UDI-Public: 00020451350776
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101035077
• Device Catalogue Number: 101035077
• Device Lot Number: 451145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other