MAUDE Adverse Event Report: JOLIFE AB LUCAS(R) 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 99576-000051

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

Patient Problem Cardiac Tamponade (2226)

Event Date 12/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.Physio performed a clinical review of the information that was reported.The following are the conclusions from the clinical review: lucas performs compressions according the guidelines for manual cpr with a depth of 5 cm and a rate of 100-120 compressions per minute (see footnote 1).The described complication, in this case, is known in the published scientific literature.Epicardial and pericardial bleeding occur in 11% - 13% of patients when manual cpr or mechanical cpr has been performed (see footnote 2).The patient was on anti-thrombolytic treatment, this may have contributed to the bleeding, which was confirmed by the customer. it is likely that the mechanical chest compressions may have contributed to the reported bleeding.The benefit of potential return of spontaneous circulation outweighs the risk of complications from cpr.The patient survived and the bleeding did not influence the patient's outcome.Footnote 1: http://www.Lucas-cpr.Com/doc_en/100901-00_rev_a_lucas2_ifu_us_lowres.Pdf.Footnote 2: smekal d, et al, cpr-related injuries after manual or mechanical chest compressions with the  lucas device: a multi-center study of victims after unsuccessful resuscitation, resuscitation 85 (2014) 1708-1712.There was no report of a device malfunction.(b)(4).

Event Description

The customer contacted physio-control to report that a patient suffered from deteriorating circulation and pericardial fluid collection, causing tamponade after they had been treated with a lucas® 3 chest compression system.The patient had collapsed at the hospital and resuscitation with lucas was initiated.After approximately ten minutes return of spontaneous circulation (rosc) was achieved.The patient then underwent a percutaneous coronary intervention, a lad (left anterior descending coronary artery) angioplasty, and a drug eluting stent was placed.The same evening the patient suffered from deteriorating circulation and pericardial fluid collection, causing tamponade.This was diagnosed using ultrasound.  an emergency thoracotomy was done, a hematoma was removed from the patient's pericardium.The doctor stated that the patient being on antithrombotic treatment (acetylsalicylic acid and ticagrelor and enoxaparin) had probably contributed to the bleeding.The patient survived.

• Brand Name: LUCAS(R) 3 CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer (Section G): JOLIFE AB # 3005445717; ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer Contact: todd bandy ; 11811 willows rd ne; remdond, WA ; 4258674000
• MDR Report Key: 6234391
• MDR Text Key: 64239326
• Report Number: 3015876-2017-00015
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 99576-000051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2016
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2017
• Date Device Manufactured: 09/14/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75