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

Model Number 526000-01

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 06 jun 2017 arjohuntleigh was informed about an event which occurred at (b)(6).Although no direct indication of the failure was stated by the facility, it is suspected that the event may have been related to the problem with garment deflation when in use with flowtron acs900.No injury to patient was reported.Despite the attempts of contact with the facility, no further information was gathered.Initially, it was stated that the system was quarantined and arjohuntleigh was requested by the facility to follow up on the next day.During the next attempt to access the involved system, it appeared impossible to trace the equipment.Arjohuntleigh decided to report this event in abundance of caution, due to possible patient's outcomes and limited information received from the customer to date.

Manufacturer Narrative

This report is being filed under exemption e2012066 by getinge (b)(4) co., ltd.(registration #3005619970) on behalf of the importer arjohuntleigh, inc.Ahus (registration #1419652).An investigation was carried out into this complaint.Arjohuntleigh received a general information stating that flowtron pump malfunction in the or.Although no direct indication of the failure was stated by the facility, it is suspected that an event which occurred at kaiser sunset customer facility may have been related to the problem with garment deflation when in use with flowtron acs900.No injury to the patient was reported - it remained unknown whether there was any patient involvement at the time of the event.When reviewing similar reportable events, we have found other cases presenting a scenario of garment deflation issues.Initially, it was stated that the system was quarantined and arjohuntleigh was requested by the facility to follow up on the next day.During the next attempt to access the involved system, it appeared impossible for the facility to trace the equipment.On 09 jun 2017 a follow up attempt with the customer was made by arjohuntleigh managing director.The contact person (surgical sourcing manager) stated that neither the pump nor garments have been identified.On 30 jun 2017 arjohuntleigh sales and service representative who had originally reported the issue has confirmed that no further details regarding the event were collected.Arjohuntleigh decided to report this event in abundance of caution due to possible patient's outcomes related to the suspected type of failure and limited information received from the customer to date.Arjohuntleigh has investigated the problem of flowtron acs900 constant pressure since the date of the first incident of this nature.Despite the testing conducted, 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 which 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", performance readings directly off the system sub-components state were collected state for further analysis which took place on (b)(4) 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.However, the investigation has 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 (b)(6), 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) 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 has not been established whether the flowtron acs900 pump was used for a patient therapy at the time of the event.However, the system was suspected to have malfunctioned (not performing to specification).No adverse event (death or serious injury) was reported.

Manufacturer Narrative

This is a follow-up 2 report to the follow-up 1 report (manufacturer report number: 3005619970-2017-00021).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: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 6685393
• MDR Text Key: 79034005
• Report Number: 3005619970-2017-00021
• 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,user f
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 526000-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2018
• Distributor Facility Aware Date: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/04/2017
• Supplement Dates Manufacturer Received: 06/06/2017; 03/13/2018
• Supplement Dates FDA Received: 07/21/2017; 04/12/2018
• 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