MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM; VENTRICULAR ASSIST DEVICE

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	01/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The site reported that on (b)(6) 2024 the patient demonstrated a loss of their cough and gag reflexes, as well as diffuse weakness that was mildly asymmetric.A head ct was obtained confirming a small mca infarct.Additionally, the patient developed a gi bleed on the same day, so all anticoagulation was stopped.Neuro was consulted, and no other interventions were recommended.The site is continuing close monitoring for any neurological changes.The berlin heart excor blood pump functioned as intended, maintaining complete filling, and emptying throughout the event.Two small punctate deposits were noted on the lvad inflow at the time of the event and were stable throughout.A pump change was not performed.
Additional Manufacturer Narrative
The excor blood pump (lvad), s/n, (b)(6) is in use on the patient since (b)(6) 2024.We have reviewed the production records of the excor blood pump, s/n (b)(6), this pump was produced according to our specification.

• Brand Name: BLOOD PUMP PU VALVES 50 ML, IN/OUT Ø12 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 18609141
• Report Number: 3004582654-2024-00007
• Device Sequence Number: 2465924
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: 04260090040010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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: 08/31/2025
• Device Model Number: P50P-001
• Device Catalogue 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: Not provided
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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: Other
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 33 KG