MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pumps pu valves; 50 ml in/out; ø 12 mm; lvad, sn (b)(6) was in use on the patient only during transition from centrimag.We have reviewed the production records of the excor blood pump lvad, sn (b)(6) and the pump was produced according to our specification.The other pump sn (b)(6), rvad associated with this event is submitted as 3004582654-2024-00040.As of 8/22/2024, the patient is stable and is fully supported by the berlin system.
Event or Problem Description
Berlin heart inc.Clinical affairs was informed by the clinic that the patient, who had only cannulas implanted, had presumed anoxic brain injury.When transitioning from centrimag to berlin heart excor active system, excor blood pump pu valves; 50 ml in/out; ø 12 mm; lvad, sn (b)(6) and rvad sn (b)(6) were inadvertently connected incorrectly (ra to ao and lv to pa).The team rapidly identified it, but the patient decompensated, requiring epi, defibrillation, and intubation to protect the airway.According to the site, the excor blood pumps did function as intended with improper cannula connections to the berlin heart pump.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 20043391
• Report Number: 3004582654-2024-00039
• Device Sequence Number: 18116855
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: (01)04260090040010(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: P50P-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG