MAUDE Adverse Event Report: BERLIN HEART GMBH BERLIN HEART EXCOR DRIVING TUBE, BLUE; VENTRICULAR ASSIST DEVICE

Model Number	L20H-003X01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube (blue) with lot number 00083102 was used from 2020-08-05 to 2021-05-14 (282 days).We have reviewed the production records of the excor driving tube with the lot number 00083102.This driving tube was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
Berlin heart (b)(4) was informed by the site via the hotline that a leakage was detected in the driving tube of the excor blood pump of a patient supported in the bvad configuration.The driving tube was exchanged in the clinic.The exchange was performed without complications and the patient is doing well.
Additional Manufacturer Narrative
During investigation, two cut-like cracks were detected at the transition to the pump connector.Crack 1 is approx.8 mm in the circumferential direction while crack 2 runs in the longitudinal direction and separates the driving tube approx.1.5 cm from the end.Both cracks were identified as cuts.It is very likely that the longitudinal cut (crack 2) was intentionally made in order to be able to separate the driving tube from the pump connection after identifying the first crack.The circumferential cut (crack 1) was probably caused by a sharp object.In the current instructions for use (ifu), the user is advised to ensure that the cannulae and driving tubes are not subjected to any tension, torsion, pressure, or traction.Also, the user is advised against touching the cannulae and driving tubes with sharp-edged objects, that can do damage to the material.And further on, in the manual the user of excor is instructed to inspect the blood pumps, cannulae and driving tubes regularly.

• Brand Name: BERLIN HEART EXCOR DRIVING TUBE, BLUE
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 11913506
• Report Number: 3004582654-2021-00030
• Device Sequence Number: 19913068
• Product Code: DSQ
• UDI-Device Identifier: 04260090040577
• UDI-Public: 04260090040577
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 03/31/2022
• Device Model Number: L20H-003X01
• Device Catalogue Number: L20H-003X01
• Device Lot Number: 00083102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR