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

Model Number	C80G-021M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Berlin heart inc.Clinical affairs was informed by the clinic on 2024-07-29 that there had been a crack on the arterial cannula for small children ø 6 mm; l 25 cm on (b)(6) 2024.The defect appeared to be at the cannula connection.Blood was noticed on the floor.Both inflow and outflow cannula were clamped and the patient was intubated.At the time of the report, the affected portion of the cannula had been trimmed off and discarded by the site, and no photos of the crack were taken.The patient recovered in the icu after the event with no deficits noted.At the time of the report, the affected cannula had been disposed of by the site, and no photos of the crack were taken.
Additional Manufacturer Narrative
The cannula (lot no.00132837) was in use on the patient from 2023-12-12 until the time of the event on 2024-07-29 (230 days).We have reviewed the production records of the excor arterial cannula lot no.00132837.This product was produced according to our specification.According to the production records, a total of 5 cannulas with this lot number were produced and all were distributed in the usa.All of the 5 cannulas were used on patients: 3 cannulas are still on the patients, the cannula associated with this complaint has been explanted as the patient was transplanted, and 1 cannula is no longer on the patient as the care has been withdrawn.There are no additional complaints associated with this lot number.It is not possible to investigate the event further as no pictures of the alleged crack were provided by the clinic and they have disposed of the affected cannula.
Additional Manufacturer Narrative
The cannula (lot no.00132837) was in use on the patient from 2023-12-12 until the time of the event on 2024-07-12 (213 days).The incorrect event date as well as the usage days of the pump were entered inadvertently in box h11.They have been revised.The initial mdr described that it is not possible to investigate the event further as no pictures of the alleged crack were provided by the clinic and they have disposed of the affected cannula.However, the code 4115 for type of investigation in box h6 was omitted.The code has beed added.

• 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: 20033732
• Report Number: 3004582654-2024-00038
• Device Sequence Number: 17746008
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)260531(10)00132837
• 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: 2023
• 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: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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 Expiration Date: 05/31/2026
• Device Model Number: C80G-021M
• Device Lot Number: 00132837
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2024
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 9 KG