MAUDE Adverse Event Report: MEDELA AG SYMPHONY PUMP (UNKNOWN); PUMP, BREAST, POWERED

Model Number SYMPHONY PUMP (UNKNOWN)

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Bacterial Infection (1735)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

Customer service responded that it would be best for the customer to call in so that additional troubleshooting could be performed.Multiple attempts to contact the customer to get additional information and to get the product for evaluation have gone unanswered.Based on the results of ca11-001, it cannot be definitively concluded that the pump caused or contributed to the customer¿s mastitis.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 and 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) 2017, the customer alleged via email to customer service that her symphony pump was not working and it was generating an error message.Customer service recommended that she reboot the pump.On (b)(6) 2017, the customer emailed back that even after rebooting the pump, it was still generating an error message and then shuts down.She also alleged that she has had mastitis for which she had to have surgery.

• Brand Name: SYMPHONY PUMP (UNKNOWN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; barr zug 6341 ; SZ 6341
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6770210
• MDR Text Key: 81918818
• Report Number: 1419937-2017-00218
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K151632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SYMPHONY PUMP (UNKNOWN)
• Device Catalogue Number: SYMPHONY PUMP (UNKNOWN)
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2017
• Date Manufacturer Received: 07/25/2017
• 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