MAUDE Adverse Event Report: BERLIN HEART GMBH ATRIAL PEDIATRIC CANNULA (WITH MANDREL); VENTRICULAR ASSIST DEVICE

Model Number	C23-004M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Site contacted berlin heart, inc (bhi) on (b)(6) 2023 to report a disruption in the inflow cannula at the inflow connection of the blood pump.By report, the nurse was called into the patient's room by the patient's parent and noted a large amount of blood in the bed.Surgical team was called to the bedside and the cannulas were clamped and the ikus was stopped.Patient was emergently transitioned to ecmo support via berlin heart cannulae.Site reported that the damaged portion of the cannula was cut off and removed with the excor blood pump prior to the transition to ecmo support.Berlin heart clinical affairs requested that the damaged portion of the cannula and the blood pump be returned to bhi for evaluation.However, site informed bhi that the cannula and blood pump will be retained by the site for third-party evaluation, and thus, they will not be returned to bhi.
Additional Manufacturer Narrative
The excor cannula lot 00098458, was in use by the patient from (b)(6) 2022 until the event on (b)(6) 2023 (200 days).We have reviewed the production records of the excor cannula lot 00098458.This cannula was produced according to our specification.Thorough evaluation will be performed once the product is returned to berlin heart.A detailed investigation report will be provided as soon as it is available.According to the site patient expired (b)(6) 2023, after withdrawn the support.Site reported this incident under mw5114230.
Additional Manufacturer Narrative
On 2023-06-05, the cannula (c23v-004m, lot no.00098458) including cannula parts of different material and origin and the blood pump with parts of cannulae were returned to berlin heart gmbh for analysis.The analysis consisted of only non-destructive visual inspection, microscopic images, and several high-resolution ct scans.Ct scans were performed by an external laboratory under the observation of the manufacturer.Ct scans were performed with a resolution of approximately 15 m as a 360° full scan.This allowed a partitioning of the 3d geometry over all axes for the investigation.For finding & conclusion see attached failure investigation report.

• Brand Name: ATRIAL PEDIATRIC CANNULA (WITH MANDREL)
• 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: 16208927
• Report Number: 3004582654-2023-00002
• Device Sequence Number: 19871685
• Product Code: DSQ
• UDI-Device Identifier: 04260090041291
• UDI-Public: 04260090041291
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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: 08/31/2023
• Device Model Number: C23-004M
• Device Catalogue Number: C23-004M
• Device Lot Number: 00098458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2020
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 12 KG