MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED

Model Number 57081

Device Problem Increase in Suction (1604)

Patient Problem Injury (2348)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.In follow up with a complaint handler on (b)(6) 2017, the customer alleged that after using the pump in style for ten weeks (the last 2 of those weeks, she was also using the symphony), she didn't feel like it had issues with suction, but she was consistently getting clogged ducts, none of which developed into mastitis.After having to undergo multiple forms of treatment for clogged ducts (lecithin and therapeutic ultrasound), her doctor ordered a symphony hospital grade pump for home use.Due to being an exclusive pumper and the lack of portability of the symphony, however, she continued using the pump in style when out and the symphony when at home.At the ten week mark, the pump in style began to turn on full suction, even if the vacuum level was barely out of the zero position.This was very painful and not remedied with hitting the let down mode and putting the pump in expression mode.After a few minutes, it would turn down the suction without her doing anything, then after another minute or so, it would "rev" back up to full suction, again without her doing anything.The increased suction caused her to have sore nipples and areola, due to having her entire areola pulled into the breast shield.This was very unpleasant, but she felt she had no other choice but to continue use, because she didn't want to quit feeding her baby breast milk.She confirmed that the replacement pump was working without issue, though her confidence level in it was not high.She alleged that since she was consistently using the symphony for half of the pumps she does in a day and the pump in style for the remaining pumps that she does when at work or out of the house, she has not had any more clogged ducts.She indicated that she does not plan on returning to solely using the pump in style, as it seems to be the reason she was getting clogs to begin with.Though it cannot be definitively concluded that the pump caused or contributed to the customer¿s clogged ducts, medela is filing this report as the customer received medical treatment.

Event Description

On (b)(6) 2017, the customer alleged to medela (b)(4) that the suction on her pump in style breast pump was too high.She indicated that when using it on the lowest vacuum level, the suction was high and, after a few minutes, it "revs up" on its own and then eventually goes back to where it started.She alleged that it feels like it is ripping her nipples apart and indicated that it pulls in her areola.She also uses a symphony breast pump with the same breast shields and does not have an issue with it pulling in her areola.She has experienced clogged ducts with the pump in style, which is why she started using the symphony.

Manufacturer Narrative

The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit and it passed suction and cycle specifications.Refer to attached evaluation.The customer's complaint of high suction and a speed issue could not be confirmed.

• Brand Name: BREASTPUMP PNSA STARTER
• Type of Device: 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: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 7151276
• MDR Text Key: 95935220
• Report Number: 1419937-2017-00367
• Device Sequence Number: 1
• Product Code: HGX
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57081
• Device Catalogue Number: 57081
• Device Lot Number: 438775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/18/2017
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other