MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. FLOWTRON ACS900; SLEEVE, LIMB, COMPRESSIBLE

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

The customer reported that a patient developed deep vein thrombosis (dvt).The allegation concerns flowtron pumps not functioning properly.A manufacturer's investigation is ongoing to verify the allegations and the reason for the development of dvt.At this time, a correlation between the pump and the development of dvt has not been identified, however this event in reported taking a cautious approach.

• Brand Name: FLOWTRON ACS900
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 16427899
• MDR Text Key: 310066444
• Report Number: 1419652-2023-00016
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2023
• Distributor Facility Aware Date: 01/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization