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

Model Number	101037810
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 the patient called in to medela llc and alleged that the liberty negative pressure wound vacuum had been turned off two days ago due to an air leak alarm, which the patients' nurse stated led to a wound infection.He additionally alleged that he was being treated in the hospital with antibiotics for the infection.
Additional Manufacturer Narrative
Customer service referred the patient to call the distributor in order to arrange a return and replacement of the device since it was not in use by the patient at the time of the call.In follow up with a medela clinician on (b)(6) 2022, the customer confirmed he had experienced an infection, but he was using the liberty negative pressure wound vacuum again and it was working without issue.The clinician asked if she could speak with his nurse but the patient hung up on her stating he did not have time.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).

• Brand Name: LIBERTY RENTAL PUMP WITHOUT CASE
• Common Device Name: 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: 13181013
• Report Number: 1419937-2022-00002
• Device Sequence Number: 17240825
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Lay User/Patient
• Device Model Number: 101037810
• Device Catalogue Number: 101037810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male