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	Insufficient Information (4580)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's dressing has been changed three times in the last couple of days.The patient refused to do any troubleshooting, states his wife is a wound care specialist and she has been treating him and has been doing his dressing changes.He stated he is experiencing bruising around the wound and may have an infection.He will be getting a culture to have tested.The patient was advised to contact his doctor to let them know what he is experiencing.Apria will be sending out a new pump.On (b)(6) 2021, melody from apria called and she's been trying to reproduce the issue the customer was experiencing.The customer has been asking for multiple units.They alleged that the patient may be dropping the pumps.A medela clinician contacted the patient on (b)(6) 2021, the patient received a new pump on (b)(6) 2021 but it was not put back on the patient as of yet.The patient's wife alleged that the wound was infected and they had a culture done on (b)(6) 2021 and they were awaiting the results of the culture.The medela clinician followed up with the patient on (b)(6) 2021, they still were awaiting the culture results but the replacement pump was working as expected.On (b)(6) 2021, the medela clinician followed up with the patient and spoke with his wife, she stated the new device is working as expected.He is being treated with oral ceftin for klebsiella.She also reported that she suspects that he may have gotten the wound infection from being in the doctor's office.She reported that every time they go to the wound doctor they have extremely long wait times.She stated all is well.Medela is filing this report, which is considered a serious injury as it required medical attention (medication was prescribed).
Event or Problem Description
On (b)(6) 2021, medela llc was made aware that the patient's liberty pump was not working like it was supposed to.There was a container issue.

• 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: 12453000
• Report Number: 1419937-2021-00076
• Device Sequence Number: 17173647
• Product Code: OMP
• UDI-Device Identifier: 07612367015578
• UDI-Public: 7612367015578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080357
• 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: 08/23/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other