MAUDE Adverse Event Report: MEDELA AG DOMINANT FLEX PORTABLE LOANER; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 0710002L

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

Patient Problem Stroke/CVA (1770)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

The device will be requested for investigation.According to (b)(4) (distributor), the patient is doing well so far.Currently stryker is in contact with the hospital and is waiting for further information including: what was the relationship between the adverse event (stroke) and the medela dominant flex pump? does the physician allege any malfunction of the medela dominant flex pump for this procedure? did the medela dominant flex pump perform as intended? provide the catalog # and serial # of the medela dominant flex pump was the medela dominant flex pump prepared as per the instructions for use? was the medela dominant flex pump confirmed to be in good condition prior to use? a follow up report will be submitted when further information is received.

Event Description

On (b)(6) 2020, (b)(4) (distributor) reported to medela (b)(4) in (b)(6) that a hospital reported to them on (b)(6) 2020 that a patient had suffered a stroke on (b)(6) 2020, beyond 48 hours after a study procedure in which a medela dominant flex device (serial number unknown) was used.

Manufacturer Narrative

Additional information received from the patient's physcian: 1.What was the relationship between the patient's stroke to the medela dominant flex pump? - device did not cause stroke.2.Does the physician allege any malfunction of medela dominant flex pump for this procedure? - no.3.Was medela dominant flex pump device performed as intended? - yes.4.Please provide the catalog # and serial # of axs medela dominant flex pump - not provided.5.Was medela dominant flex pump prepared as per dfu? - yes.6.Was medela dominant flex pump confirmed to be in good condition prior to use? - yes.

• Brand Name: DOMINANT FLEX PORTABLE LOANER
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug,
• MDR Report Key: 10014016
• MDR Text Key: 193327533
• Report Number: 1419937-2020-00040
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K130123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0710002L
• Device Catalogue Number: 0710002L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other