MAUDE Adverse Event Report: MEDELA AG LIBERTY SALES PUMP; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 0871000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 08/01/2019

Event Type  Death  

Manufacturer Narrative

A medela clinician attempted to contact the distributor to get additional information, with no response as of the date of this report.The medela clinician followed up with the medela sales representative, who indicated that the device may have been used over exposed bowel and the pressure was set at -125mmhg, when the doctor's order was for -100mmhg, although the distributor was not able to fully confirm the details when she reported it to the sales representative.It is unknown if a contact layer or white foam was used to protect the sensitive structures and it cannot be confirmed what at pressure the device was set.Although at this time it cannot be confirmed if the liberty suction pump caused or contributed to adverse event, medela is filing this report due to patient death.

Event Description

On (b)(6) 2019, a distributor customer alleged to a medela sales rep that in early (b)(6) 2019 a patient had experienced bleeding while using a liberty negative pressure wound therapy device and was subsequently taken to the hospital where the patient passed away.The customer additionally alleged that they were not aware of the issue at the time it occurred and when the pump was returned to them, they sent out for use with another patient, with no reported complaints or issues.

Manufacturer Narrative

The device was evaluated by the manufacturer on 05/04/2020, and during a review of all logged alarms and events there was no evidence to show any unintended function of the pump and based on the data it can be concluded that the pump worked as intended and according to the specifications.Please reference attached evaluation.

• Brand Name: LIBERTY SALES PUMP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug
• MDR Report Key: 9199889
• MDR Text Key: 162598693
• Report Number: 1419937-2019-00135
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K080357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 0871000
• Device Catalogue Number: 0871000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death