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

Model Number 101037810

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

The pump was replaced by (b)(4) on (b)(6) 2021 and was not returned to medela.Medela is filing this report, which is considered a serious injury as it required medical attention.Also see related medwatch 1419937-2021-00060 and 1419937-2021-00061.

Event Description

On (b)(6) 2021, medela was made aware of a third pump that the patient received related to medwatch 1419937-2021-00060 and 1419937-2021-00061 that was reported not working as expected.Sn (b)(4) was delivered to patient at (b)(6) house on (b)(6) 2021.Sn (b)(4) is being replaced by (b)(4).Patient called (b)(4) on 7/19/2021 at 10pm.(b)(4) is replacing the pump on (b)(6) 2021.(b)(4) stated that the pump was not working and they would replace.The call was not transferred to medela for troubleshooting.Medela customer service spoke with (b)(6), (b)(4), at the (b)(6) who provided the history of the above serial numbers.Medela customer service reviewed their phone records and the only interaction the patient had with medela was on (b)(6) 2021 and (b)(6) 2021.Patient did not contact his nurse or physician and was aware of the 2 hour window.

• 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 ; 4358316
• MDR Report Key: 12320540
• MDR Text Key: 266617616
• Report Number: 1419937-2021-00062
• Device Sequence Number: 1
• Product Code: OMP
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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