MAUDE Adverse Event Report: MEDELA INC. PUMP IN STYLE ADVANCED TOTE; HGX

Model Number 57063/9207010

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

A replacement transformer was sent to the customer.The product involved in the complaint was not returned for evaluation/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.This issue with the damaged transformer housing for the pump in style device was addressed in (b)(4).The investigation found that the transformers are being damaged during shipment from the manufacturer to medela.This damage is causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the transformers to medela is 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 has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.

Event Description

The customer reported to customer service that the transformer housing on her pump in style advanced tote completely cracked, exposing the inner circuitry, which is a safety risk.

• Brand Name: PUMP IN STYLE ADVANCED TOTE
• Type of Device: HGX
• Manufacturer (Section D): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer (Section G): MEDELA INC.; 1101 corporate dr.; mchenry IL 60050
• Manufacturer Contact: donald alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8155782270
• MDR Report Key: 5148116
• MDR Text Key: 28581207
• Report Number: 1419937-2015-00303
• 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: Patient
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 57063/9207010
• Device Catalogue Number: 57063/9207010
• Device Lot Number: REV M - 1212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1