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

Model Number 526000-01

Device Problem Device Handling Problem (3265)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 19 aug 2016 arjohuntleigh received the information about an incident which occurred with one of our devices- flowtron acs900 pump.The patient has fallen- was found on the floor face down, probably during the attempt to go to the bathroom with garments still attached.As a result, the patient had a fractured humerous.Basing on the information gathered to date, a posey alarm which should alert the staff about patient's fall was not working properly (not an arjohuntleigh equipment).As per information received: "she was going to the bathroom and made it as far as the venodyne tubing let her go and then she went forward and hit her shoulder.She had a fractured humerus, no surgical intervention.".

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Arjohuntleigh received the information about an incident which occurred with one of our devices- flowtron acs900 pump.The patient has fallen during the attempt to go to the bathroom with garments still attached.Patient was found on the floor face down.As a result, the patient had a fractured humerus.No surgical intervention was required.When reviewing similar reportable events, we have found no other cases presenting a similar scenario as claimed in this complaint.Thus, the occurrence rate observed for this failure mode is currently considered to be low.The system should be used as a part of prescribed plan of care, combined with an individualized monitoring programme, not to be used in a home healthcare environment.If the patient's condition changes, the overall therapy regimen should be reviewed.A proper garment application and connection to the pump is essential.Flowtron acs900 pump is not designed with a quick release system for the tubing.The pump is incorporated in two tubeset connectors which are responsible for the garment attachment.The connector in the end of each tubeset has a push button which is colour-coded and has a number marked on it: blue "1" or orange "2".Push button is to be used in order to detach a garment tube from the tubeset connector.It is not allowed to pull the garment without the press button being pushed.Flowtron acs900 pump includes a unique cable management system which aids tubeset and power cord management in the clinical area and during transportation and storage.Retaining clips help to secure the tubing in order to manage it properly in the healthcare environment.There are two options of the tubeset length, depending on the dedicated use: std- standard = 2,1 meters / 7ft.Long and or - operating room = 4 meters/ 13ft.Long.The pump involved in the incident was a 526000-01 model, std type with a tubeset 2,1 meters long.As per the instruction for use: "where appropriate, patients should be instructed in the proper use of the system, the purpose of the therapy and that any problems should be reported to the nursing staff." it appears most likely that the patient who did not notify the facility caregiving staff, made an attempt to go to the bathroom without previous detachment of garments connected to the flowtron acs900 pump.Pump and garment tubing has limited patient's moving ability, resulting in the fall.Basing on all the information gathered, it may be considered that the root cause of the reported incident is related to the use error.The patient tripped because they did not follow the procedure to detach the garments.Also there was a failure of a fall alarm (non-arjohuntleigh equipment; the cable was frayed and the alarm was not audible): such alarm will not prevent a patient to exit their bed but it can exasperate the situation by not alarming nursing staff to such exit after it takes place.Arjohuntleigh recommends to remind the facility about designed features of the flowtron acs900, especially in terms of garments disconnection.This is to be communicated to the customer.It has been established that the acs900 pump was used for a patient treatment at the time of the event and contributed to the outcome of the event.However, the device was not found to have malfunctioned (was performing to specification) when the event took place.Due to the nature of this incident we are reporting this event to competent authorities.

• Brand Name: FLOWTRON ACS900
• Type of Device: JOW
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5959083
• MDR Text Key: 55013622
• Report Number: 3005619970-2016-00017
• 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
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/17/2016,08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 526000-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2016
• Distributor Facility Aware Date: 08/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2016
• Date Manufacturer Received: 08/19/2016
• 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): Required Intervention