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

Model Number	L20H-002X01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Berlin heart inc.Was informed by the clinic via hotline that a leak was detected in the driving tube of the excor blood pump of a patient supported in the lvad configuration.The pump function was not affected with complete emptying and filling.The driving tube was changed without incident.The patient was not negatively affected by the exchange and is doing well.
Additional Manufacturer Narrative
We have reviewed the production records of the excor driving tube lot no.00128331.This product was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
The excor driving tube lot no.00128331, was in use on the patient for 214 days until the time of the event.On 2024-01-17 the driving tube in question was returned to berlin heart gmbh for investigation.During the initial visual inspection of the returned driving tube, the break in the driving tube described was detected.The overall appearance of the damage indicates a massive bending stress that occurred directly at the pump connection.It is most likely that the damage was caused due to excessive external forces.
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 (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: 18259804
• Report Number: 3004582654-2023-00037
• Device Sequence Number: 15418771
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: (01)04260090040560,(17)251231,(10)00128331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00128331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/25/2023; Not provided
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/12/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 17 KG