MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number P15P-001

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

Patient Problem Ischemia Stroke (4418)

Event Date 04/09/2024

Event Type  Injury  

Manufacturer Narrative

The excor blood pumps, s/n, (b)(6) (rvad) was in use on the patient from 2024-03-26 until the time of the event for 14 days.We have reviewed the production records of the excor blood pump, s/n (b)(6), the pump was produced according to our specification.The left excor blood pump will be submitted as 3004582654-2024-00023.A detailed investigation report will be provided as soon as it is available.

Event Description

The site reported that the patient, who was originally implanted with bvad excor blood pumps on 2024-03-26 had a stroke on 04/09/2024, and the left side of the body was lightly recovering.Patient was neither intubated nor sedated.According to the site, the patient previously had viral infection at the time of implantation and later bacterial infection.Fibrin clots were observed on both the pumps.Thrombectomy was performed and fibrin was removed after the stroke event and deposits are under control.However, slight deposits were found in both pumps, especially in the right side.The pumps functioned as intended.The patient was withdrawn from support upon request by the patient's family and died on (b)(6) 2024.

• Brand Name: BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM
• Type of Device: VENTRICULAR ASSIST DEVICE
• 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: 19164061
• MDR Text Key: 340835414
• Report Number: 3004582654-2024-00024
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 04260090040157
• UDI-Public: 04260090040157
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: P15P-001
• Device Catalogue Number: P15P-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 21 MO
• Patient Sex: Male
• Patient Weight: 9 KG