MAUDE Adverse Event Report: MEDELA AG VARIO18 AC/DC,100-240V,PT-C; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 026.5112

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2023

Event Type  Death  

Event Description

On 3/15/2023, medela ag was informed that a patient died in a medical center during a procedure involving an airway suction with the affected device.According to the medical center it is still unclear if the device caused or contributed to the event or if the handling of the device played a role.

Manufacturer Narrative

Medela ag immediately got in contact with the respective medical center in order to collect further relevant information to the case.It was decided to send an official medela representative to the medical center in the following days in order to view and confirm the set up and handling of the device.Return of the affected unit is already under way for a technical investigation.

Manufacturer Narrative

The official medela representative visited the medical center and tested the affected device on site.All tests with the affected device were successful and it was concluded by the official medela representative that the device is working as expected.It was confirmed by the staff of the medical center that the checks before use as described in the official instruction for use were not conducted.Additionally, the official medela representative provided training to the medical staff of the medical center on the proper usage of the vario pump.Further, a technical investigation of the affected device was performed by medela ag.The technical investigation showed that the affected device was indeed working according to specifications.The final conclusion of medela ag is that the affected device was properly working and did not cause the incident.

• Brand Name: VARIO18 AC/DC,100-240V,PT-C
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• 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: tom cuzman ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 16585740
• MDR Text Key: 311711433
• Report Number: 3002807523-2023-00003
• Device Sequence Number: 1
• Product Code: BTA
• UDI-Device Identifier: 07612367016056
• UDI-Public: 7612367016056
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 026.5112
• Device Catalogue Number: 026.5112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2023
• Date Manufacturer Received: 06/13/2023
• 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): Death