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

Model Number	A06-009
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor connecting set for cannulas ø 6/9 mm (lot 00140046) was in use on the patient from (b)(6)2024 until the time of the event on (b)(6)2025 (101 days).We have reviewed the production records of the connecting set lot no.00140046.This product was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On (b)(6)2025, the site contacted berlin heart inc.Clinical affairs (ca) to report an issue with the excor connecting set for cannulas ø 6/9 mm (lot 00140046).The site noted that blood was observed around the cannula connection.The site replaced the blood pump with the connecting set without any complications.Previously on (b)(6)2025, the site also reported an anomaly with the same connecting set, which involved "bulging or bubbling" with black film around the outflow connector.Upon evaluation of the pictures provided by the site, ca recommended that the site closely monitor the connector and report again as soon as there is a change in its appearance.Throughout the event, the pump maintained complete filling and ejection, and the patient remained hemodynamically stable with no significant clinical complications.
Additional Manufacturer Narrative
On 2025-03-04, the excor connecting set, lot no.00140046 was returned to berlin heart gmbh for investigation.The affected connecting set was returned to berlin heart gmbh together with the excor blood pump, which were in use on the patient for 101 days until the connecting set and the blood pump were exchanged.The reported abnormality was only confirmed based on the pictures and videos provided by the clinic at the time of the event.Analysis of these pictures revealed that the reported anomaly occurred only on the outflow connector of the blood pump.No such anomalies were present on any of the other connector areas.The returned blood pump and the connecting set appeared to be rinsed.It appeared that they had probably been rinsed by the clinic.No deposits or other abnormalities were found in the outflow side connector during initial visual inspection.Based on previous similar cases, the patient's mobility can cause the cannula to kink at this area.It is likely that some blood entered between the cannula and the connector at this location due to possible factors such as patient's mobility or positioning / fixation of the blood pump or dressing changes that may have impacted the form of the cannula.However, it is notable that deposits were only seen on the exterior of the outflow connector.Therefore, the exact cause for the anomaly is unable to be determined.

• 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 21657478
• Report Number: 3004582654-2025-00016
• Device Sequence Number: 12618560
• Product Code: DSQ
• UDI-Device Identifier: 04260090040591
• UDI-Public: (01)04260090040591(17)270131(10)00140046
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: A06-009
• Device Lot Number: 00140046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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: 22 MO
• Patient Sex: Male
• Patient Weight: 12 KG