MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. FLOWTRON ACS 900; JOW

Model Number 526000-06

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

Patient Problem Skin Discoloration (2074)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The flowtron acs900 pump involved in the event has been returned to the manufacturer for further evaluation and it has been tested.There was not possible to recreate the event.No issues have been found regarding the pump during 2 weeks of tests performed to date.The pump has worked as intended.Further analysis is underway to determine root cause of the event.Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(4) 2016, arjohuntleigh received a customer complaint where it was reported that flowtron acs900 pump held the constant pressure in one garment and the patient's leg appeared discoloured.

Manufacturer Narrative

An investigation was carried out into this complaint.Based on the information received, the flowtron acs900 pump held the constant pressure in one garment and the patient's leg appeared discoloured.The nurse stated that pump was inflating only one calf.Acs900 held pressure for an extensive period of time and did not adjust to the appropriate cycle times.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 (b)(4).It has been established that the acs900 pump was used with the l501 m garment for a patient 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 r&d center for further investigation.Despite multiple testing conducted the root cause of the problem cannot be established as the failure mode cannot be duplicated.Methods of testing performed by arjohuntleigh included the steps as follows: checked the garments were inflated up to 40mm hg with a hand pump containing a pressure gauge to confirm a proper vent rate, recorded results every 30 seconds.All garments were able to reach the defined pressure and results were comparable to the control garment.Visual inspection of pumps and a diagnostic check of the startup and initial settings - no visual anomalies were found, no errors occurred during the startup.Verified the internal pressure reading of the pump against the actual measured output - measurements were accurate and comparable to the actual pressure.Connected returned garments to pumps in several combinations of power source and environmental conditions - all pumps were functioning normally, venting between inflation cycles, although they were exposed to various temperature levels with a changeable power source and running time.Internal inspection of pumps supported by technical experts no anomalies found.Ultimate performance test - pumps were connected to the 230v power supply and left running continuously.They have been running with no alarms or adverse events for 23 days at the time of the report.To conclude, the unit was performing up to specification when tested.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: 3005619970-2016-00006) 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 the first incident of this nature (april 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 3rd may, 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 (b)(4).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 ACS 900
• 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: 5636473
• MDR Text Key: 44564681
• Report Number: 3005619970-2016-00006
• 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: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 526000-06
• 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: 04/08/2016
• Device Age: 3 MO
• Event Location: Hospital
• 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