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

Device Problems Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Investigation is in progress, a follow-up report will be submitted upon investigation completion.Serial number not provided.

Event Description

Arjo learned of a patient who developed deep vein thrombosis (dvt).The allegation concerns flowtron pumps not functioning properly.An 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 arjo is reporting this event taking a cautious approach.

Manufacturer Narrative

Information is still collected for the analysis.The follow-up report will be provided upon completion of the investigation.

Manufacturer Narrative

The customer reported that the flowtron acs9000 pump was found to be not functioning (garment not being recognized), the therapy was not being delivered and a patient developed a dvt (deep vein thrombosis).The pump and garment are not available for inspection, because several pumps were used for this patient and neither pumps nor garments were isolated by the customer.As per the customer clinical product manager, the patient was a critically ill inpatient receiving sequential compression device (scd) therapy and anticoagulation therapy at the time.The patient developed a dvt and other clots throughout his body.He later expired due to total organ failure, which was confirmed by the customer as unrelated to the flowtron device.On april 13, additional information received indicated that as per the internal customer protocol the presence of the dvt before treatment is not checked.The customer stated that they did not perform a scan for this patient untill the 5th day of their treatment.The patient was scanned after multiple pump changes during the first days of the patient's treatment.As per the product instruction for use a ¿known or suspected acute deep vein thrombosis, thrombophlebitis or pulmonary embolism¿ constitute contraindication of using the system.The flowtron acs900 pump is equipped with the lcd screen which shows different icons depending on the pump status.When the garment is not recognized, the lcd screen will communicate the issue via displaying leg pictogram on the pump monitor.As per the instruction for use (ifu 526933en_13) "a garment connected but not inflated is shown as an outline on the leg icon.When it is inflated, the garment outline is filled in black"; "a garment connected but not inflated is shown as an outline on the leg icon.When it is inflated, the garment outline is filled in black", no garment outline on the leg icons, indicates that no garments are connected to either tubeset.Before the therapy, it is recommended to check the lcd screen icons to confirm that the correct type of garment(s) have been connected and during garment inflation, to check the lcd screen to confirm that there are no fault indicators displayed and that the correct pressure is being supplied.Allegedly the device failed and the therapy was not delivered for the patient who developed a dvt.This complaint was deemed reportable taking a cautious approach.Since the pump and garment were not isolated for the product evaluation and the patient was using several pumps at that time, additionally the patient was critically ill and the presence of the dvt was not checked before therapy, the correlation between the pump and the development of a dvt was not established.Therefore, in the course of the investigation we were not able to identify reasonable information indicating that the garment non-recognition issue would lead to a serious injury in the future.If new information is available, that could change the current knowledge, the future failures will be assessed accordingly.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16427895
• MDR Text Key: 310068437
• Report Number: 3005619970-2023-00004
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

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
• Date Manufacturer Received: 04/13/2023
• 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): Hospitalization