MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS ® CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Sepsis (2067)

Event Date 10/10/2021

Event Type  Death  

Manufacturer Narrative

The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.Stryker performed a clinical review of the reported event and determined that the device use may have contributed: based on the information in the publication, it cannot be excluded that the compressions from the lucas device caused pulmonary contusion.

Event Description

Stryker performed a literature review, which described the following event: "a 57-year-old male with a history of morbid obesity (bmi 49) presented to an outside hospital with chest pain and subsequently went into cardiac arrest.Adult cardiac life support (acls) was promptly initiated, relying on the lucas device to deliver compressions for a period of over 1 hour while the patient was cannulated onto veno-arterial extracorporeal membrane oxygenation (va-ecmo) via the femoral vein and femoral artery.A distal perfusion catheter was added to promote lower extremity perfusion.Emergent cardiac catherization subsequently revealed complete occlusion of the left anterior descending artery and was treated with drug eluting stent placement.Post-intervention, the patient had worsening lactic acidosis and shock despite maximum vaecmo support and was transferred to our institution for advanced heart failure management." "the lucas was mispositioned and caused sternal and rib injuries leading to significant pulmonary contusions, necrotizing pulmonary infection, and severe sepsis." the patient eventually passed away.

• Brand Name: LUCAS ® CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16283655
• MDR Text Key: 308632615
• Report Number: 3005445717-2023-00037
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White