MAUDE Adverse Event Report: MEDELA AG LIBERTY RENTAL PUMP WITHOUT CASE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 101037810

Device Problems Energy Output Problem (1431); Obstruction of Flow (2423)

Patient Problem Unspecified Infection (1930)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

The customer was contacted by a medela clinician to get additional information, with no response as of the date of this report.Medela is filing this report, which is considered a serious injury as it required medical attention.

Event Description

On (b)(6) 2022 the customer alleged to medela llc that they had a system clogged alarm while using the medela liberty negative pressure wound therapy pump.Additionally, the mother states there is nothing wrong with the dressing on the pump, they need more canisters to be delivered to the hospital, as the patient is being admitted to the hospital for a blood infection.The nurse explained that the device may be removed because they may change the plan of care while in the hospital.The mother states that no one can do the dressing change but the surgeon.He has to come to the hospital each time to have the dressing changed.On (b)(6) 2022, a second call from the mother tonight and she states that there was an alarm and the pump went out.She does not know what type of alarm, and the device is not longer connected to the patient.She refused to reconnect the patient to the unit to troubleshoot.States that the surgeon is the only person that can connect the pump to the patient.She says the surgeon is not available to troubleshoot with them, surgeon has already left the room.This nurse explained to the mother that it is likely that the issue is not the device because it is not likely that three negative pressure wound therapy pumps have the same issue.The dressing should be applied differently to eliminate the notion of a pump problem.At the request of the mother the patient will receive another pump exchange.Doctor was at the bedside assessing the wound.

• Brand Name: LIBERTY RENTAL PUMP WITHOUT CASE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug 6341 ; SZ 6341
• Manufacturer Contact: dave kurudza ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 14488943
• MDR Text Key: 292519704
• Report Number: 3002807523-2022-00006
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080357
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101037810
• Device Catalogue Number: 101037810
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2022
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• 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
• Patient Sex: Male