MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

Model Number 57063

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement power supply and return of her original power supply was requested for testing/evaluation.The customer was contacted by a complaint handler to get additional information on 08/09/2018.The customer responded on 08/22/2018 and indicated that she received the replacement power supply and it was working without issue.The transformer was returned and was evaluated on 08/22/2018.The customer's report of a breached power supply housing was confirmed.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the power supply to medela was not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process was modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength was also increased to further protect the power supply during shipping.Since then, as a part of routine continuous improvement activities, a rev p power supply has been distributed to market, manufactured under a revised design and by a different manufacturer.

Event Description

On (b)(6) 2018 the customer alleged to medela llc that the power supply housing for her pump in style breast pump was cracked and had exposed wires.The customer indicated that she was not using the pump, but was preparing it for her new baby and noticed the broken housing when she took the pump out of the box, where she had previously stored it.

• Brand Name: PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 7818172
• MDR Text Key: 118533369
• Report Number: 1419937-2018-00186
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 57063
• Device Catalogue Number: 57063
• Device Lot Number: 9207010 REV M 3512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1