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

Model Number	P25P-001X01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(6) on the patient was in use from (b)(6) 2023 until the time of the excor removal on (b)(6) 2023 (40 days).We have reviewed the production records of the excor blood pump, s/n (b)(6), this pump was produced according to our specification.
Event or Problem Description
Berlin heart clinical affairs was informed by japan distributor that a patient had a neurological dysfunction symptom.Scheduled pump exchange due after 1 year of use of the pump was postponed due to the patient's health condition (severe infection).When the patient became stable the pump was exchanged on (b)(6) 2023.However, a thrombus was found inside the new pump.Therefore, the pump was converted from excor to centrifugal pump (biofloat) on (b)(6) 2023.After conversion, hemiplegia appeared on (b)(6) 2023.Two ct scans revealed an enlarged cerebral infarction and a widespread brain tumor.
Additional Manufacturer Narrative
Data corrected in section d to match device information in gudid per the fda letter dated 5/20/2024.D1 changed the brand name to match gudid d2a changed the common device name to match gudid d4 udi changed, to include complete udi number (di+pi) (01) (b)(4).

• 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: 18310964
• Report Number: 3004582654-2023-00038
• Device Sequence Number: 12329077
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: (01)04260090040119,(17)250630,(21)2022144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 06/30/2025
• Device Model Number: P25P-001X01
• Device Catalogue Number: P25P-001X01
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 14 KG