MAUDE Adverse Event Report: BERLIN HEART GMBH CONNECTOR SET FOR CANNULAE Ø 6/ 9 MM; VENTRICULAR ASSIST DEVICE

Model Number	A06-009
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The connector set for cannulae, lot 00116205, on the patient at the time of the event was in use from (b)(6) 2022 (93 days).We have reviewed the production records of the excor connector set, lot 00116205 and lot was produced according to our specification.
Event or Problem Description
Berlin heart, gmbh was notified by the site that during a connecting set change, a small amount of blood ( less than 2 mls ) was observed during the final cable tie removal.The connecting set was being exchanged due to thrombus.The side cutters were kept in the same position to provide slight pressure for prevention of further blood loss.A sterile field was prepared, the lvad blood pump was paused, and the affected connecting set was exchanged without untoward effect to the patient.Upon removal, a small longitudinal slit was seen (approx.3 mm) at the position of the cable tie.Of note, the cable ties were being removed with the side cutters.The clinic disposed of the effected connecting set tubing, therefore, the product is not available for further investigation.

• Brand Name: CONNECTOR SET FOR CANNULAE Ø 6/ 9 MM
• 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: 15014181
• Report Number: 3004582654-2022-00032
• Device Sequence Number: 19436507
• Product Code: DSQ
• UDI-Device Identifier: 04260090040591
• UDI-Public: 04260090040591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/14/2022

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: 12/31/2024
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00116205
• 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: 06/23/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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: 19 MO
• Patient Sex: Male