MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O. O. DVT GARMENTS

Model Number L501-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was carried out into the complaint.Arjohuntleigh received a customer complaint where it was reported that the patient was diagnosed with cellulitis occurred several weeks after orthopedic surgery and the patient's discharge from the facility.We have found (b)(4) other cases (reported from the same facility) presenting similar symptoms as claimed in this complaint (cellulitis reported occurring a couple weeks after usage of garments).The occurrence rate observed for this failure mode is currently considered to be very low and isolated to this facility only.It can be established that the dvt prevention system consisting of flowtron acs800 pump and l501m calf garments was being used for patient care during his stay in the hospital.No malfunctions were indicated with either pump or garment, that could have caused or contributed to the event.Following the above, the dvt prevention system was found to have been up to the specification when the event took place.The arjohuntleigh dvt prevention systems are clinically effective, non invasive, mechanical prophylaxis systems designed to reduce the incidence of dvt during all types of major surgery.It is also suitable for other patient groups including neurology, critical care, general medical and obstetrics.The treatment with use of arjohuntleigh systems needs to be combined with an individualized monitoring program.Based on collected information to date (however very limited) and clinical expert opinion, we believe that the cellulitis could occurred due to some bacteria appearance.The cause of cellulitis is a bacterial infection.The infection occurs most often due to mechanical damage to the skin (e.G.After forging ears, tattooing, after surgery), burned or bite.In accordance to the flowtron asc800 instruction for use (ifu) 513933en_02: - "the flowtron acs 800 system, when used with the dvt calf / thigh garments, should not be used in the following conditions: (.) any local condition in which the garments would interfere, including: · gangrene, · recent skin graft, · dermatitis, · on untreated, infected leg wounds." - "garments should be positioned in such a way that they do not create any potential for constant pressure points on the patient's limb.Additional care should be taken when placing the garments on any deformed leg or foot, or on legs with significant oedema." - "garments should be removed immediately if the patient experiences tingling, numbness, or pain, and the physician notified." - "garments are for single patient use only.Do not use the garments on a different patient after treatment." - "the system should be used continuously for no less than 72 hours post operatively or until the patient becomes fully ambulatory." by taking into account that each garment is packed in a sealed bag, absence of complaints volume with similar scenario when compared to the amount of sold devices and that the similar cases occurred in the same hospital only with one surgeon, it appears to be highly unlikely that the cellulitis reported can be result of arjohuntleigh garments application.In conclusion, due to very limited information received, we are not able to identify the root cause of cellulitis occurrence.Arjohuntleigh identified towards the customer staff the need to regularly checked / monitored patients to ensure proper therapy is being provided.

Event Description

On 11 may 2016 arjohuntleigh received a customer complaint where it was indicated the hospital experienced 5 6 episodes of lower limb cellulitis in patients (post orthopedic surgery provided by the same surgeon) that were diagnosed a few weeks post discharge.The flowtron acs800 and l501m garments were used during the hospitalization and discontinued prior to discharge.Upon post discharge follow up physician visit, the cases of cellulitis were diagnosed which required oral antibiotics it was indicated that one or two patients diagnosed with cellulitis necessitated readmission for the cellulitis.It was indicated that the hospital converted to arjohuntleigh in the fall of 2015 and it was reported that no other processes, procedures, or equipment have changed except for new dvt prophylaxis devices.

• Brand Name: DVT GARMENTS
• Type of Device: DVT GARMENTS
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5807968
• MDR Text Key: 49947473
• Report Number: 3007420694-2016-00128
• 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: company representative,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/20/2016,05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L501-M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Distributor Facility Aware Date: 05/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other