MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. FLOWTRON ACS900; JOW

Model Number 526000-01

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem Skin Discoloration (2074)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2016 arjohuntleigh received a customer complaint where it was indicated that after using flowtron acs900 system it was noticed that the patient's foot was purple.The pump held the constant pressure in the garment placed on the patient's foot.It was reported that the patient's foot became to normal.

Manufacturer Narrative

An investigation was carried out into this complaint.Based on the information received, the flowtron acs900 pump flowtron acs900 system held the constant pressure in the garment located on the patient's foot.After the procedure being performed on the patient, when surgical drapes were removed, it was noticed that the patient's foot became purple.It was reported that the unit itself did not alarm or provide any indication that something was not working properly.The patient's foot returned to normal.No injury to the patient occurred.When reviewing similar reportable events, we have found 3 other cases presenting a similar scenario as claimed in this complaint.However, the occurrence rate observed for this failure mode is currently considered to be low (0,01%).It has been established that the flowtron acs900 pump was used for patient's therapy at the time of the event and contributed to the outcome of the event due to a constant pressure applied by the pump.Based on the above, the pump was found to have malfunctioned (not performing to specification) when the event took place.The pump has been returned to (b)(4) dvt repair center for further investigation.Despite multiple testing conducted the root cause of the problem cannot be established as the failure mode cannot be duplicated.To conclude, the unit was performing up to specification when tested and was released for further use.In summary, upon arjohuntleigh investigation it was possible to establish that the device has failed to meet the specification when the event took place which occurred during the patient treatment.The device was directly involved in the reported adverse event however after the comprehensive test perform we could not duplicate the failure and are not able to confirm a complaint.Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution.

Manufacturer Narrative

This is a follow-up 2 report to the follow-up 1 report (manufacturer report number: 3005619970-2016-00007) that was submitted on 07 jul 2016.In the course of further investigation of the reported failure mode the following has been established: arjohuntleigh has investigated the problem of flowtron acs900 constant pressure since the date of the first incident of this nature (b)(6) 2016).Upon arjohuntleigh's examination, the involved device was comprehensively tested and functioned as expected.A suspected symptom of no deflation could not have been recreated.The exact root cause of the problem could not have been determined as the failure mode could not have been duplicated until the later date.Conclusions of arjohuntleigh investigation remained unchanged until another incident occurred on (b)(6) 2017 in the usa.This was the first time arjohuntleigh have been able to see and test the unit in the "failed" state, which appeared to be an investigation milestone.The unit was left connected to mains power in the "failed" state, performance readings directly off the system sub-components state were collected for further analysis which took place on (b)(6) 2017.The investigation was divided into hardware and software potential failure areas which were objects of verification.At no point during this investigation was the r&d team able to replicate the actual failure, only fabrication of the failure was achieved.The data gathered during the activities of the on-site visit aided in determining that the fabricated failure and the actual failure state are very similar.The only difference being that in the actual failure serial communications with the system control circuit board are not functional, while they are functional during the fabricated state.This indicated that the system was in fact in the secondary state, which is entered only when a software application failure is detected by the system.Investigation course regarding software and hardware specific issues did not allow defining the exact root cause of the observed failure.The investigation has however, with a high degree of confidence, shown that software version 2.000 will handle the failure state in a more resilient manner when stimulated by any potential cause leading to the failure state.If the failure state occurs in a device with software version 2.000, the device will reset, restart, and therapy will continue.The specific symptom observed in the field may, with a high degree of confidence, be addressed by upgrading devices to software version 2.000.Arjohuntleigh initiated a global recall on 01 jun 2017 with an internal reference number fsn-suz-001-2017.Potentially affected pumps (serial numbers between (b)(4) and (b)(4) are supposed to be corrected in the field via a software upgrade to version v2.000.The appropriate communication to customers is being distributed.It needs to be emphasized that responsible care must be taken when using any part of a device that comes into contact with a patient or user.Patient's skin should be inspected frequently during procedures as per the instruction for use (526933en).Garments should be removed immediately if the patient experiences tingling, numbness or pain.Clinical judgement is required to determine if the patient's skin condition requires additional protective measure or if the therapy should be discontinued and an alternative modality used.It has been established that the flowtron acs900 pump was used for a patient therapy at the time of the event.The system malfunctioned (did not perform up to manufacturer specification) when the event took place, the patient suffered from foot discoloration.

Manufacturer Narrative

This is a follow-up 3 report to the follow-up 2 report.Arjo has continued the investigation towards flowtron acs900 deflation failure and was able to replicate the reported fault.This allowed to identify the root cause of the investigated problem.Garment over inflation occurs when the flowtron acs900 pump is entered to the state in which it experiences a specific number of power on/off cycles.The issue is caused a timer operating system resource being over allocated.The symptom of the investigated problem reveals when the final power on sequence begins.It was found out that this problem may occur in the field in a number of ways: membrane keypad hardware failure.Users pressing the power button quickly.The power button being used as a therapy start/stop button.The most likely scenario is that the power button is used to stop and then start the therapy.Note that it has always been intended that the end user should use the center play/pause button to start and stop therapy.Every time the power button is used to start therapy, a new timer operating system resource is created, leading to a software fault.Version 2.000 software forces the pump to completely reset whenever the operating system failure occurs.This results in therapy being restarted and prevents an attached dvt garment from failing to deflate.The pump continues the therapy after the reset.We have confirmed that the specific symptom observed in the field can be addressed by upgrading devices to software version 2.000.

• Brand Name: FLOWTRON ACS900
• Type of Device: JOW
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road; suzhou industrial park; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 5646167
• MDR Text Key: 44894417
• Report Number: 3005619970-2016-00007
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 526000-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2018
• Distributor Facility Aware Date: 04/11/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/12/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FSN-SUZ-001-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Other