MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN; VENTRICULAR ASSIST DEVICE, PRODUCT CODE:DSQ

Model Number	C80G-021M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	08/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula lot 00089633, was in use by the patient from 2021-04-12 until 2021-08-08 (118 days).We have reviewed the production records of the excor cannula lot 00089633.This cannula was produced according to our specification.At the current status we do not have enough information to draw any conclusions about the connected cannula.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted berlin heart inc.On (b)(6)2021 to report that a patient being supported with an excor blood pump in the lvad configuration experienced a massive bleeding event on (b)(6) 2021.The site reported that the grandmother raised the patient from a lying to a sitting position in the patient´s bed and noticed a sudden appearance of a large amount of blood.The medical teams immediately came to the bedside but were not able to determine the source of the bleeding.A code was called and the patient was volume resuscitated.The attending physician tried to hand pump the device with no success as the patient had not enough intravascular volume.The excor cannulas were clamped off and the medical team emergently placed the child on ecmo for volume replacement and circulatory support.When ecmo was initiated, the attending physician found a breach in the arterial cannula at the junction to the connecting set.The site reported when they called on (b)(6) 2021 that the patient was being supported on ecmo, with the excor blood pump cannulas still connected to the patient but clamped off, but that the exsanguination event led to a severe cerebral and intestinal hypoxic injury, documented by imaging, and that care was being withdrawn due to the patient´s poor prognosis.
Additional Manufacturer Narrative
Inadvertently product model numer & lot number reported in the intial mdr.
Additional Manufacturer Narrative
On august 23, 2021, the affected cannula, including the connector set and the connected blood pump, was returned for analysis.The analysis consisted of several high-resolution ct scans, which were carried out by a specialized laboratory.The cannula was initially examined as it was received by berlin heart, then after cleaning and finally in a dismantled condition.All investigation steps were carried out under the supervision of an independent observer and documented by him.Observations: a breach of the cannula was identified about 5-6 mm long.The breach was located above the edge of the connector, under the edge of the first cable tie.The connector edge and the cannula show no deviations from the specifications.The position of the rupture was oriented to the patient's body.At the time of the investigation, the position of the first cable tie was not according to the ifu.At the time of the investigation, the length of the distal end of the cannula, without polyester velour covering, was not according to the ifu.Conclusion: the cannula might have been stretched several times caused by moving the pump upright from the patient's body during routine examination of the blood pump or excessive movement from the patient.This could have led to increased internal material stresses in the silicone of the cannula wall and may have resulted in a breach due to tensile stress.Due to the position of the cable tie and the remaining length of the distal end of the cannula without polyester velour covering, the flexibility of the cannula wall was severely restricted.This could have led to increased internal material stresses in the silicone of the cannula wall and may have contributed to the fracture of the cannula wall due to external kinking and/or tensile stress.

• Brand Name: EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN
• Common Device Name: VENTRICULAR ASSIST DEVICE, PRODUCT CODE:DSQ
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 12391469
• Report Number: 3004582654-2021-00042
• Device Sequence Number: 17170114
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: 04260090040492
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 08/31/2021

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: 04/30/2023
• Device Model Number: C80G-021M
• Device Catalogue Number: C80G-021M
• Device Lot Number: 00094254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 08/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/10/2021; 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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: 21 MO
• Patient Sex: Female
• Patient Weight: 11 KG