MAUDE Adverse Event Report: BERLIN HEART GMBH APEX PEDIATRIC CANNULA 9/12MM STAGED; VENTRICULAR ASSIST DEVICE

Model Number	C22A-004
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula, lot: 00085562, was in use by the patient from on (b)(6) 2022 until on (b)(6) 2023 (339 days).We have reviewed the production records of the excor cannula, lot: 00085562.This cannula 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 a cut in the silicone part and velour part of the inflow cannula.It resulted in bleeding from the apical cannula in the area of damaged cannula.The blood pump including the extension set was replaced without any problems on (b)(6) 2023.The site reported that the damaged portion of the cannula was cut off prior to the pump exchange.
Additional Manufacturer Narrative
The clinic informed ca on 11/26/2022 of a cut in the inflow cannula including the silicone part and the velour.However, the cut did not penetrate through the cannula wall and no leak was observed.The affected cannula had been in use on the patient for 293 days up to the time of the incident.The clinic provided berlin heart with two pictures of the cannula at the time of the incident.After careful review of the situation, it was recommended to remove the damaged portion and use an extension set to connect to the blood pump.However, clinic did not follow the berlin heart instructions.Berlin heard gmbh received the cannula for investigation on 02/08/2023.Visual inspection of the returned cannula pieces confirmed the cut in the inflow cannula piece.Additionally, a cut was also found on the the outflow cannula and the silicone tube of the cannula adapter set too.Based on the shape of the cuts, the damaged was most likely caused by a sharp object.The ifu explicitly warns that blood pumps, cannulae and driving tubes must not be touched with sharp objects (e.G.Surgical instruments).Otherwise, the components may be damaged.There is a risk of inadequate support or blood loss.

• Brand Name: APEX PEDIATRIC CANNULA 9/12MM STAGED
• 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: 16241022
• Report Number: 3004582654-2023-00004
• Device Sequence Number: 15091251
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: 04260090040492
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 06/30/2022
• Device Model Number: C22A-004
• Device Catalogue Number: C22A-004
• Device Lot Number: 00085562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: Male
• Patient Weight: 10 KG