MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number	P30P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6) on the patient since (b)(6) 2024 until the time of the event on 2024-02-25 (16 days) we have reviewed the production records of the excor blood pump s/n (b)(6).This pump 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 notified berlin heart inc.Clinical affairs that a pump change had occurred on a patient being supported with the excor pediatric vad system due to an audible "crunching" noise.Additional information provided by the site, on (b)(6) 2024, reported that the patient was exhibited ldh lab values consistent with hemolysis.The patient's ldh level increased from 508 on (b)(6) 2024 to 1200 on (b)(6) 2024.According to the site, the blood pump maintained complete filling and ejection throughout.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), was in use on the patient until the pump exchange (16 days).On 2024-03-13 the blood pump in question was returned to berlin heart gmbh for investigation.We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specifications.During initial visual inspection of the returned blood pump, no abnormalities were found.The blood pump was tested for functional performance as well as noise emission.The pump performance met our specifications.The blood pump was completely filling and emptying, and the membrane movement showed no abnormalities.Operating noises could be heard during the test.The noises could not be assessed as crunching.The complaint could not be confirmed.For further evaluation, the blood pump was disassembled, and individual membrane layers were individually tested.All three layers of the membrane were intact and the graphite distribution was uniform without any gaps.The stabilizing ring was without any defects.No vibration of the valve leaflets was detected.No crunching noises were detected during testing.Therefore, no correlation between the pump and increased hemolysis values of the patient could be detected.Neither a defect nor a malfunction could not be detected.All examinations revealed no abnormalities.The blood pump met its specifications.

• Brand Name: BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• 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: 18880014
• Report Number: 3004582654-2024-00015
• Device Sequence Number: 7839269
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: P30P-001
• Device Catalogue Number: P30P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 10 KG