MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR ACCESSORY SET PU VALVES; VENTRICULAR ASSIST DEVICE

Model Number	T00L-002
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor accessory set pu valves, lot number 00120199 has been used during the implantation on (b)(6) 2023.We have reviewed the production records of the excor accessory set pu valves, lot number 00120199.This product was produced according to our specification.Product were not available for evaluation.The de-airing tubing is not glued to the stop cock, it is slid on with a tight fit.Ifu 1000721x18 rev 15 (page 102) clearly indicates never to pull on the de-airing tube, when removing the de-airing needle.Since no product were returned, we are unable to determined the exact casue for the recorded complaint.
Event or Problem Description
The site contacted clinical affairs to report that the surgeon attempting to de-air the blood pump when the stopcock at the end of the priming tube became dislodged from the tubing.As a result, air was entrained in the blood pump.While the de-airing process was ultimately completed.

• Brand Name: EXCOR ACCESSORY SET PU VALVES
• 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: 16229759
• Report Number: 3004582654-2023-00003
• Device Sequence Number: 12130899
• Product Code: DSQ
• UDI-Device Identifier: 04260090040553
• UDI-Public: 04260090040553
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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: 01/31/2025
• Device Model Number: T00L-002
• Device Catalogue Number: T00L-002
• Device Lot Number: 00120199
• 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: 01/03/2023
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: 20 MO
• Patient Sex: Female
• Patient Weight: 9 KG