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

Model Number	L20H-002X01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube (red) with lot number 00086180 was used from (b)(6) 2020 to (b)(6) 2021 (242 days).We have reviewed the production records of the excor driving tube with the lot number 00086180.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 clinic via the hotline that a crack was detected in the driving tube near the driving tube port of the excor blood pump of a patient supported in the lvad configuration.Configuration.The pump function was not affected.The pump continued to perform as intended with complete fill and ejection.The driving tube was exchanged without incident by experienced personnel in the clinic.The patient was not negatively affected by the exchange and is doing well.
Additional Manufacturer Narrative
During investigation, two breaks were detected at the transition to the pump connector and close to the cable tie.The two cracks look different, which indicates different types of stress on the driving tube.At this region of the driving tube, there is a transition from smaller diameter to larger diameter.This transition area of the driving tube is where the most stress is applied by external forces when in use by a patient.Torsional stresses can occur in the area of the cable tie when the driving tube is turned.It is very likely that high stress from the patient's mobility may have caused the fractures in the driving tube, and the presence of a small surface damages indicate that high degree of movement must have occurred at this region and contributed to the fracture.The exact cause of the defect cannot be detected in this case.In the current instructions for use (ifu), the user is advised that the cannula and driving tubes must not be bent, since this could lead to the damage of the cannula and driving tube.Furthermore, the user is advised to ensure that the cannulae and driving tubes are not subjected to any tension, torsion, pressure, or traction.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, RED
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 11646907
• Report Number: 3004582654-2021-00022
• Device Sequence Number: 3658545
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 06/30/2022
• Device Model Number: L20H-002X01
• Device Catalogue Number: L20H-002X01
• Device Lot Number: 00086180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR