MAUDE Adverse Event Report: JOLIFE AB LUCAS 2; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

First: no patient or employee exposure or cross contamination occurred in either of the following incidents.The ed employs two lucas 2 automatic compression devices.The units were deployed about three months ago without incident.An unresponsive patient arrived at 1903 to the ed and was subsequently intubated and massive transfusion protocol (mtp) started for gi bleed.The patient proceeded to have a sudden change in rhythm at 2027 into asystole and cpr was started.The lucas device was utilized for consistent cpr.After the patient was transported to icu, the device was being cleaned to place back in service.The staff noted that the more they tried to clean, blood continued to seep out of the backplate.The unit was removed from service.I spoke to the physio rep and the field services department at physio the next day to find out if this was a 'frequent' occurrence.Field rep stated he was only aware of three incidences of contaminated backplates.The recommended conclusion was to dispose in bio hazard trash and order a new backplate.A new backplate was ordered that same day and arrived ten days later and the unit was placed back in service.Unfortunately, another incident occurred two days later with the second lucas device in the ed.The patient arrived at 1545 with cpr in progress.The lucas was deployed at 1600 until 1610 when compressions were held and patient was noted to have carotid and femoral pulses.The patient received a bedside bronch at 1833.At 1915 the total fluid of the orogastric/nasogastric (og/ng) was recorded at 5000 ml of bloody fluid.The patient was subsequently admitted to the icu.The lucas backplate from this device was also noted to have bloody fluid continuing to seep from the seams as it was being cleaned.It was also removed from service and a replacement board was ordered five days later.The backplate from the second incident was opened by a staff member to explore the reason the backplate continued to seep blood after multiple attempts to clean.The reason for the report is to have these incidences reported and request the manufacturer to make a backplate that has seams and screws that are sealed, making the plate impermeable to blood/body fluid exposure and therefore easier to clean without incident.

• Brand Name: LUCAS 2
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; us agent: paula lank physio-control, inc.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 5789721
• MDR Text Key: 49424313
• Report Number: 5789721
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LUCAS 2
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1