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

Model Number	A09-009
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extension set (lot 00156115) was in use on the patient from 2025-10-02 to the cannula was replaced on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (3 days) after the extension set was placed on the patient.The affected cannula extension set was not returned to berlin heart for investigation, as the extension set in question was already discarded after replacement.Therefore, neither the failure nor the cause of the failure in question could be determined.We have reviewed the device history record (dhr) of the extension set lot no.00156115.This product was produced according to our specifications.According to the production record, a total of 6 extension sets with this lot no.Were produced.All extension sets were distributed in the usa.There are no more complaints associated with this lot number except the current complaint.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on 2025-10-05 to report a cannula breach that had occurred on the patient being supported with excor pediatric ventricular assist device in bivad configuration.According to the site, the patient was sitting up in bed, coughed, and blood started coming out of the rvad outflow excor cannula extension set, a09-009 just above the titanium connector of the blood pump.The nurse pinched the cannula, the outflow cannula was clamped, and the extension set was changed.The patient remained hemodynamically stable throughout and continues at their neurological baseline.At the time of the report, the 9-9 extension in question had already been disposed of and no pictures were available.

• 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23413903
• Report Number: 3004582654-2025-00059
• Device Sequence Number: 8929177
• Product Code: DSQ
• UDI-Device Identifier: 04260090040171
• UDI-Public: (01)04260090040171(17)280518(10)00156115
• Combination Product (Y/N): N
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A09-009
• Device Lot Number: 00156115
• 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: 10/05/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 20 KG