MAUDE Adverse Event Report: JOLIFE AB LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 3302430

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

Patient Problems Laceration(s) (1946); Sepsis (2067)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the available information, there is no indication of a device malfunction or a use error associated with the reported event.Physio continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer reported to physio-control that cpr was provided by a lucas 2 chest compression system (device) to a patient being treated for cardiorespiratory arrest.It was reported that, following the use of the device, the patient developed some rib fractures and a hepatic laceration that required an embolization.The patient was later transferred to another hospital and developed a sepsis on a superinfected hepatic hematoma that required bi-segmental hepatic resection.The patient's outcome was not reported.The customer reported that the use of the device may have caused or contributed to the hepatic laceration which required embolization by surgical intervention.

Manufacturer Narrative

The customer reported to physio-control that the patient survived the reported event.The customer also reported to physio-control that the device was being used to administer chest compressions for 20 minutes.Additionally, they indicated that they were unaware if the device stabilization strap was used during the event.Based on the available information, there is no clear indication of a device malfunction or a use error associated with the reported event.A clinical review of the reported issue was performed by (b)(4) and physio-control with the following feedback/conclusions: complications involving the liver are known to occur with manual cpr as well as mechanical cpr.In this case it is unclear if the suction cup was placed correctly.Therefore, it is difficult to determine if the injury was caused by correct manual or mechanical cpr or by a misplacement of the device on the patient.However, with the information provided it is possible that lucas compressions contributed to the reported liver laceration.As described in the scientific literature, the risk of complications from cpr never outweighs the benefit of return of spontaneous circulation.Knowing the risks is important for treatment issues after rosc, because both manual and mechanical cpr may lead to injuries.Platenkamp et al, complications of mechanical chest compression devices.Neth heart j.2014 sep; 22(9): 404¿407.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevägen 17; ideon science park; lund 22370 ; SW 22370
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund 22370 ; SW 22370
• Manufacturer Contact: jason march ; 11811 willows road ne; po box 97006; redmond, WA ; 8004421142
• MDR Report Key: 5524361
• MDR Text Key: 41118490
• Report Number: 3015876-2016-00340
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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
• Distributor Facility Aware Date: 02/23/2016
• Event Location: Other
• Date Manufacturer Received: 07/12/2016
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR