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

Model Number 526000-01

Device Problem Infusion or Flow Problem (2964)

Patient Problem Skin Discoloration (2074)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has received an information about an event which occurred with the involvement of flowtron acs900 pump and leg garment of unknown type.Facility biomed has received an internal service report on the pump with an annotation that after the garment was released from the patient and the leg, the leg was observed to be discoloured (purple).The severity of patient injury is unknown.Following the initial reporter's allegation, patient's leg turned purple because the pump was not releasing air from the garment.Garments were not quarantined by the customer and it was not possible to identify their origin or type.The pump was firstly put into testing operation overnight by the facility representative and no issues were found.The pump was sent to the manufacturer for evaluation.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Arjohuntleigh has received an information about an event which occurred with the involvement of flowtron acs900 pump and leg garment of unknown type.Facility biomed has received an internal service report on the pump with an annotation that after the garment was released from the patient and the leg, the leg was observed to be discoloured (purple).The severity of patient injury is unknown.Following the initial reporter's allegation, patient's leg turned purple because the pump was not releasing air from the garment.Garments were not quarantined by the customer and it was not possible to identify their origin or type.The pump was firstly put into testing operation overnight by the facility representative and no issues were found.When reviewing similar reportable events, we have found other cases presenting a scenario of garment deflation issues.Even though no statement regarding device malfunction was provided, the investigation directed towards the problem of constant pressure by both, facility and arjohuntleigh.Flowtron acs900 unit remained in the failure state only until being discovered by attending staff.The pump was then removed, turned off and quarantined.Upon arjohuntleigh's examination, the involved device was functioning as expected.A suspected symptom of no deflation could not have been recreated.Arjohuntleigh has been investigated the problem of flowtron acs900 constant pressure since the date of the first incident of this nature ((b)(6) 2016).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 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)) 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 ((b)(4)).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 to specification) when the event took place, the patient suffered from foot discoloration.

Manufacturer Narrative

This is a follow-up 2 report to the follow-up 1 report (manufacturer report number: 3005619970-2017-00007).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: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 6492917
• MDR Text Key: 72805824
• Report Number: 3005619970-2017-00007
• 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,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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2018
• Distributor Facility Aware Date: 03/23/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided; 03/13/2018
• Supplement Dates FDA Received: 06/20/2017; 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