MAUDE Adverse Event Report: BERLIN HEART GMBH CONNECTING SET FOR CANNULA; VENTRICULAR ASSIST DEVICE

Model Number	A06-009
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor connecting set for cannula, lot number 00120918 was explanted on (b)(6) 2023 when the patient underwent a planned palliative surgical repair of her congenital heart defect with explantation of berlin heart blood pump.Removal of the affected connecting set occurred as part of the planned explantation of berlin heart and was not related to the aforementioned "cut" on the connecting set tubing.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The surgeon on site contacted berlin heart inc.Clinical affairs (ca) on (b)(6) 2023 to report an abnormality on the outflow cannula connecting set.The presence of a "blemish" was confirmed by ca with the site's vad coordinator.Ca specialist visited the site on the same day and assess the connecting set.Upon an in-person assessment of the connector, an approximately 8mm gash (cut) was noted in the outflow 6-9 connector just above the titanium connector of the pump.The gash was palpable in the outer surface of the connecting set.The immediate recommendation was made to either trim off the damaged portion of the connector, or to change the connector completely.The damaged portion of the connector was requested to be returned to bhi for further evaluation.The patient remains stable at the time of the complaint.
Additional Manufacturer Narrative
The piece of the connecting set for cannulas (a06-009, lot no.00120918) was not returned to berlin heart and therefore not available for analysis.The connecting set was in use on the patient for 91 days until the time of the event.The device record history was reviewed and no abnormalities were found.On (b)(6) 2023 we were informed that the patient was successfully transplanted on (b)(6) 2023.

• Brand Name: CONNECTING SET FOR CANNULA
• 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: 16495833
• Report Number: 3004582654-2023-00011
• Device Sequence Number: 6315970
• Product Code: DSQ
• UDI-Device Identifier: 04260090040591
• UDI-Public: 04260090040591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 04/30/2025
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00120918
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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: 8 DA
• Patient Sex: Female
• Patient Weight: 4 KG