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

Model Number	L20H-002X02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube (red) with lot number 00094146 was used from (b)(6) 2021 to (b)(6) 2021 (39 days).We have reviewed the production records of the excor driving tube with the lot number 00094146.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 that a leakage was detected in the driving tube of the excor blood pump of a patient supported in the lvad configuration.The driving tube was exchanged in the clinic.The exchange was performed without complications.The patient was not negatively affected by the exchange and the patient is doing well.
Additional Manufacturer Narrative
The excor driving tube (red) with lot number 00094146 was used from (b)(6) 2021 to (b)(6) 2021 (39 days).We have reviewed the production records of the excor driving tube with the lot number 00094146.This driving tube was produced according to our specification.The clinic has informed us that the driving tube in question was already disposed.Therefore berlin heart could not analyse the product in question.The clinic did not provide us with further information such as pictures or videos of the defect.Due to the fact, that the product was not available for analysis we can not drew any conclusion regarding the complained defect nor its cause.

• Brand Name: BERLIN HEART EXCOR DRIVING TUBE, BLUE
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 12781121
• Report Number: 3004582654-2021-00052
• Device Sequence Number: 3485733
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: 04260090040560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160036
• 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): 11/09/2021

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: 05/31/2023
• Device Model Number: L20H-002X02
• Device Catalogue Number: L20H-002X02
• Device Lot Number: 00094146
• 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: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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: 52 YR
• Patient Sex: Male