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

Model Number	C80G-021M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The excor arterial cannula for small children ø 6 mm; l 25 cm (lot no.00140688) was implanted on the patient on (b)(6) 2024.The event occurred on (b)(6) 2025, which is (269 days) after the cannula in question was placed on the patient.The cannula remained within the patient after death.The patient was upsized with 15 ml excor blood pump, connecting to the same cannula using the excor connecting set for cannulas ø 6/9 mm (lot no.00156084) on (b)(6) 2025.The excor connecting set for cannulas ø 6/9 mm (lot no.00156084) was implanted on the patient on (b)(6) 2025.The event occurred on (b)(6) 2025, which is (45 days) after the connecting set in question was placed on the patient.The connecting set is no longer on the patient.The connecting set manufacture date for this lot: 2025-06-11.The expiration date for this lot: 2028-05-18.Udi: (b)(4).We have reviewed the production records of the cannula (lot no.00140688) and connecting set (lot no.00156084).The products were produced according to our specifications.According to the production records, a total of five cannulas with this lot number were produced.All cannulas were distributed in the us and were used on patients.There are no other complaints associated with either lot number.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.(bhi) clinical affairs (ca) to report a cannula disconnection in a patient being supported with an excor pediatric lvad.The arterial cannula separated from the connecting set that was connected to the outflow limb of the blood pump resulting in exsanguination and death of the patient.The patient was originally implanted with excor arterial cannula for small children ø 6 mm; l 25 cm.According to the information provided by the site, the patient was sitting up in bed after a diaper change when she became agitated.The patient "let out a scream, and the arterial cannula popped off of the titanium connector of the 6-9 connecting set".The cannulas were immediately clamped, and the patient was resuscitated and placed on ecmo using the berlin heart cannulas.Once on ecmo, the site reported that they were unable to achieve adequate ecmo flows, and care was eventually withdrawn.The surgeon reported that this was a "cannula disconnection from the 6-9 connector, and not a breach of the cannula itself." on examination of the cannula and connecting set performed after the event, there were no rough edges or evidence of tearing on the cannula end.Additionally, there was no residual silicone from the cannula or a cable tie present on the titanium connector of the 6-9 connector set.
Additional Manufacturer Narrative
Incorrect codes for investigation findings and investigation conclusions have been entered inadvertently in the initial report.Therefore, they have been corrected from 3233 to 3221 and from 11 to 4315 in section h6.Additionally, in section h11, a sentence "a detailed investigation report will be provided as soon as it is available." has been deleted, as the affected product remained within the patient after death, and will not be available for investigation.Corrected h11: the excor arterial cannula for small children ø 6 mm; l 25 cm (lot no.00140688) was implanted on the patient on (b)(6) 2024.The event occurred on 2025-09-07, which is (269 days) after the cannula in question was placed on the patient.The cannula remained within the patient after death.The patient was upsized with 15 ml excor blood pump, connecting to the same cannula using the excor connecting set for cannulas ø 6/9 mm (lot no.00156084) on (b)(6) 2025.The excor connecting set for cannulas ø 6/9 mm (lot no.00156084) was implanted on the patient on (b)(6) 2025.The event occurred on 2025-09-07, which is (45 days) after the connecting set in question was placed on the patient.The connecting set is no longer on the patient.The connecting set manufacture date for this lot: 2025-06-11.The expiration date for this lot: 2028-05-18.Udi: (b)(4) we have reviewed the production records of the cannula (lot no.00140688) and connecting set (lot no.00156084).The products were produced according to our specifications.According to the production records, a total of five cannulas with this lot number were produced.All cannulas were distributed in the us and were used on patients.There are no other complaints associated with either lot number.

• 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: 23064314
• Report Number: 3004582654-2025-00048
• Device Sequence Number: 15915158
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)270131(10)00140688
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: C80G-021M
• Device Lot Number: 00140688
• 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: 09/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: 12 MO
• Patient Sex: Female
• Patient Weight: 4 KG