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

Model Number 57062

Device Problem Increase in Suction (1604)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Customer service did not conduct troubleshooting with the customer, as the customer indicated that she completed troubleshooting on her own using the instructions for use.Customer service requested that the customer provide proof of purchase for the pump before a replacement could be sent.On (b)(6) 2019, the customer called back, provided a proof of purchase and additionally alleged that she was saw her doctor after a referral by her lactation consultant, who prescribed her three different antibiotics, ibuprofen, and a pain killer for shooting pain and a low grade fever.She indicated that she had a hematoma during her last pregnancy and needs the pump operate at lower suction, but her pump generates suction which is too high.The customer was sent a replacement pump, nipple shields, flex breast shields and return of her original pump was requested for testing/evaluation.In follow up with a complaint handler on (b)(6) 2019, the customer indicated that she had only used the pump four times as she is trying to breast feed and only needs the pump while at work.She also indicated that the issue is a result of a hematoma she experienced with her first child which has caused her breasts to be very sensitive and that the pump is fine when in the initial expression phase, but once it transitions to the letdown phase, the pull is too strong for her sensitive breasts.In further follow up with the complaint handler on (b)(6) 2019, the customer confirmed that the replacement pump was working well.The device was evaluated on (b)(6) 2019 with the customer's parts as received and it failed vacuum testing in that vacuum was below specification for many of the required settings.The vacuum test was then conducted using a lab kit with the customer's pump and it passed.Refer to attached product evaluation.When a pump fails with the customer kit, but not the lab kit, any issue is typically attributable to the kit, not the pump.In this case, it was noted in the evaluation that the customer's connectors, tubing and valves had residue on them and the customer's valve was damaged.Refer to attached pictures.Any foreign contaminants that hinder the device's ability to form an adequate vacuum seal could potentially result in lower suction.It is very difficult to determine exactly how much contamination under normal use is needed for pump vacuum to suffer, but it is a known failure mode causing low suction.The pump in style instructions for use details cleaning procedure for the parts and accessories.It is also a common troubleshooting item to check.The customer's report of high suction could not be confirmed.Based on the results of (b)(4), it cannot be definitively concluded that the pump caused or contributed to the customer's mastitis.The estimated incidence of mastitis in lactating women, whether using a breast pump or not, according to published clinical literature can be as high as 33%.In fact, clinical guidelines suggest the use of a breast pump to facilitate withdrawal of breast milk during bouts of mastitis.The complaint rate of mastitis across all reported failures, across all medela breast pumps, is (b)(4) for the period of january 2013 to august 2017.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 & 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.[(b)(4)].

Event Description

On (b)(6) 2019, the customer alleged to medela llc that the suction on her pump in style breast pump was too high on one side, which was painful and caused shredding and bruising of her nipple.

• 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: jan kloiber ; 1101 corporate drive; mchenry, IL ; 8004358316
• MDR Report Key: 8633604
• MDR Text Key: 145848718
• Report Number: 1419937-2019-00081
• 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: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 57062
• Device Catalogue Number: 57062
• Device Lot Number: 451490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other