MAUDE Adverse Event Report: JOLIFE AB LUCAS (T) CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 3302430

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

Patient Problems Death (1802); Internal Organ Perforation (1987)

Event Date 06/06/2013

Event Type  Death  

Event Description

It was reported in an article in the journal from the american society of anesthesiologists "anesthesiology 2014; 102:00-00" that the use of a lucas 2 chest compression system on a patient, may have caused a pancreatic fracture which contributed to the patient's death.The patient was a (b)(6)-year old man with a body mass index of (b)(6) without any previous trauma, who had a sudden out-of-hospital cardiac arrest.Manual cpr was reportedly begun by an experienced first-aider during the 10 minutes before the arrival of the medical pre-hospital team.Mechanical chest compressions using the lucas were initiated by the physician who arrived on scene.The patient was transported to the hospital.On day 15, after the event, an abdomino-pelvic tomodensitometry revealed a large pancreatic pseudocyst complicating pancreatic fracture due to trauma, grade iii in the american association for the surgery of trauma classification, without any signs of bowel perforation or thoracic injuries.This pancreatic fracture was allegedly due to abdominal mechanical compression by inadvertent movement of the lucas.The patient died on day 30 after refractory ventricular tachycardia and fibrillation secondary to uncontrolled massive hemorrhage.The pancreatic fracture seemed to be the consequence of unexpected epigastric abdominal compression during automatic mechanical cpr of long duration.Reportedly, the long duration of cpr and a probable progressive movement of the device may explain the traumatic pancreatic fracture related to direct abdominal compression.It is unknown if the device stabilization strap was used during the reported event.The stabilization strap is intended to secure the correct position of lucas on the chest.Attempts to gather additional information from the author have been unsuccessful.This report has been previously reported by physio-control, inc.Under manufacturer report # 3015876-2014-00221.

Manufacturer Narrative

(b)(4).Physio-control, inc., performed a clinical review of the reported event.It was observed from the published article that both manual and mechanical cpr had been provided to the patient.The cpr provided cannot be excluded as the cause of the pancreatic injury.However, when provided in accordance to guidelines, both manual and mechanical cpr present the same potential harm.A pancreatic fracture caused by cpr is only likely to occur if the cpr has been provided on the abdomen and not on the sternum.Hence, the pancreatic fracture was likely caused by incorrect positioning of the provided cpr which is considered a use error.The device instruction for use provides warnings that incorrect positioning of the device can lead to an increased risk of damage to the rib cage and the internal organs.A stabilization strap is provided with the device to secure the correct position of the device on the patient.There is no information available to indicate whether or not the stabilization strap was used during the reported event.Physio-control has concluded that the likely cause of the reported event was due to a use error.

• Brand Name: LUCAS (T) CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevagen 17; ideon science park; lund 223 63; SW 223 63
• Manufacturer Contact: malin melander ; scheelevagen 17; ideon science park; lund 223 6-3 ; SW 223 63 ; 462865011
• MDR Report Key: 3924742
• MDR Text Key: 4517836
• Report Number: 3005445717-2014-00005
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3302430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2014
• 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): Death; Hospitalization
• Patient Age: 32 YR