MAUDE Adverse Event Report: BERLIN HEART GMBH CANNULA EXTANSION SET 6 / 9MM; 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	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extansion set, lot number 00131153 has been used during the implatation on (b)(6) 2023.We have reviewed the production records of the excor cannula extansion set, lot number 00131153.This product was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted clinical affairs to report that during the pump exchange for upsizing, the 6/9mm connectors had been placed on the 25ml pump, and after connecting the outflow connector to the outflow cannula the surgeon noticed blood leakage from the outflow connector site.The surgeon reattached the outflow cannula to the connector, but it continued to leak.The surgeon used a different connector set and attached it to the outflow cannula without issues.There was no longer a blood leakage coming from the outflow connector site.".
Additional Manufacturer Narrative
The excor cannula connecting set, lot no.00131153, was returned to berlin heart gmbh for investigation.Visual inspection of the connecting set observed no abnormalities.Then the connecting set was tested for leaks.The connecting set was pressurized approximately 280 -300 mmhg pressure and observed for pressure drop.No pressure drop was observed, indicating no leak.Therefore, unable to duplicate the leak.We have reviewed the production records of the connecting set and this product met our specifications.It was concluded that the exact cause for the reported complaint was not able to be determined.

• Brand Name: CANNULA EXTANSION SET 6 / 9MM
• 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 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 17424416
• Report Number: 3004582654-2023-00027
• Device Sequence Number: 5955092
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 03/31/2026
• Device Model Number: A06-009
• Device Catalogue Number: A06-009
• Device Lot Number: 00131153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: 2 YR
• Patient Sex: Female
• Patient Weight: 9 KG