MAUDE Adverse Event Report: MEDELA AG PUMP BASIC RACK MOBILE VERSION; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 0710001

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

Patient Problem Injury (2348)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned and evaluated on 11/18/2019 by medela ag.During the evaluation of the exterior of the device, no damage or deformation was noted.Additionally, the device powered on without issue and, during a 5 minute running test, the device ran normally and within vacuum specifications.Refer to attached test protocol.It is possible that the hospital used the device incorrectly because the device had been checked with the service department at the hospital and the pressure was correct.The hospital chose not to provide detailed information; therefore, no further information was able to be obtained regarding the patient's backgrounds and the device usage/management methods.Additionally, the extent or cause of the injuries was unable to be identified.Although it cannot be confirmed that the basic device caused or contributed to the patient's injuries, medela is filing this report.

Event Description

On 10/20/2019, a healthcare professional from centro medico teknon alleged to medela spain that in the past two months, three babies had suffered injuries during a procedure using the basic medical suction pump.

• Brand Name: PUMP BASIC RACK MOBILE VERSION
• 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: jan kloiber ; 1101 corporate drive; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 9615909
• MDR Text Key: 176223753
• Report Number: 1419937-2020-00003
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K021368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0710001
• Device Catalogue Number: 0710001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 10/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• 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