MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK; PUMP, BREAST, POWERED

Model Number 57062

Device Problems Increase in Suction (1604); Suction Problem (2170)

Patient Problem Pain (1994)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

A replacement pump was sent to the customer.In follow up with the customer on (b)(6) 2017, the customer indicated that she had open sores and blisters on her nipples from pumping, for which she was prescribed a medicated, all-purpose nipple cream.She indicated that the replacement pump was working without issue, her nipples were healing and she was no longer experiencing pain.Though the complaint information does not reasonably suggest that the device caused or contributed to the injury or the device malfunctioned, medela is filing this report, which is considered a serious injury as it required medical attention.

Event Description

On (b)(6) 2017, the customer alleged to medela llc that the suction on her pump in style breast pump was high and was not pumping rhythmically, which hurt.

Manufacturer Narrative

The device was returned without the customer's parts and accessories; therefore, it was evaluated with a medela lab kit on 03/05/2018, and, though it passed all cycle specifications, it failed minimum vacuum specifications, in both stimulation and expression phases.The pc board was replaced with a control pc board and the pump passed cycle and vacuum specifications, which indicated that there was an issue with the original pc board.The customer's report of high suction was confirmed.[(b)(4)].

• Brand Name: PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK
• 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: 7128360
• MDR Text Key: 95230136
• Report Number: 1419937-2017-00354
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Device Lot Number: 438350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/22/2017
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other