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	03/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 03/26/2020, a medela clinician contacted the patient's daughter to get additional information.The daughter alleged that her father was placed on the device on saturday, (b)(6), and the alarmed during that night.The daughter indicated that her father lives with his girlfriend and said that the girlfriend told her father that the device was alarming; however, neither her father nor his girlfriend contacted medela nor the device distributor regarding the pump alarm at that time.The daughter was made aware of the alarm when she arrived on monday, (b)(6) 2020, to take her father to a doctor visit, at which time, the patient was admitted to the hospital, where he spent two (2) nights on iv antibiotics.The patient was released from the hospital and was doing better, taking oral antibiotics, and was placed back on the medela liberty device, which was working without issue.The medela clinician discussed with the daughter the need to have traditional dressing available in the home so that, if needed, the patient could be removed from the negative pressure device and that if the device was not working for two (2) hours or more, that her father must be transitioned to the traditional dressing.The daughter indicated that the doctor also provided her with that information.The patient is scheduled to see the podiatrist every other day.The clinician also reminded the daughter to call medela at any time if there is an issue.The daughter verbalized understanding of all of the clinician's directions.The clinician left the daughter her direct phone number should any questions or issues arise.The system clogged alarm is generally indicative of one or more of the following: twisted, kinked or clamped tubing, which needs to be corrected.Clogged tubing, which needs to be replaced.Full canister, which needs to be replaced.Clogged canister filter, which needs to be replaced.
Event or Problem Description
On 03/25/2020, a customer alleged to medela llc that the liberty negative pressure wound therapy device which was placed on her father generated a "system clogged" alarm on (b)(6) 2020 and fluid was not moving from the dressing.She further alleged that her father was admitted to the hospital on (b)(6) 2020 and placed on iv antibiotics for an infection caused by the device not working.

• 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
• MDR Report Key: 9973203
• Report Number: 1419937-2020-00036
• Device Sequence Number: 2897760
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 03/25/2020
• Initial Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other