MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM; VENTRICULAR ASSIST DEVICE

Model Number	P25P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), was in use on the patient for 35 days from (b)(6) 2023 until the pump exchange on (b)(6) 2023.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
Berlin heart gmbh was informed by the clinic that the patient's ldh level increased to 1836 on 2023-12-04.The clinic considered the possibility that the cause could be attributed to the patient, since the patient had a mechanical valve in his atrioventricular valve therefore, performed various tests including ct.The results showed no abnormalities.Therefore, the pump was replaced on (b)(6) 2023 and ldh values dropped to 1218.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), was in use on the patient until the pump exchange (35 days).We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specifications.Berlin heart received the blood pump for evaluation on 2023-12-28.During initial visual inspection of the returned blood pump, deposits could be detected on the valves.The blood pump was cleaned and disinfected before the test for functional performance.However, some residues remained from the deposits on the valves.The pump performance met our specifications.No squeaking or whistling noises were detected during the examination.The thickness values of the valve leaflets are within the specifications.The valves functioned according to specifications, during the production tests and in the functional test.No vibration of the leaflets was detected.Neither a defect nor a malfunction could be detected.The blood pump met its specifications.It was also determined that there was no disturbance of the surface in the blood-carrying area of the blood pump that could have caused deposits.No correlation between the increased hemolysis values of the patient and the pump could be determined.Whether the deposits on the valves contributed to hemolysis could not be determined.The cause of the deposits is most likely patient related.

• Brand Name: BLOOD PUMP PU VALVES 25 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: 18476281
• Report Number: 3004582654-2024-00002
• Device Sequence Number: 6923749
• Product Code: DSQ
• UDI-Device Identifier: 04260090040119
• UDI-Public: 04260090040119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 06/30/2025
• Device Model Number: P25P-001
• Device Catalogue Number: P25P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: 8 YR
• Patient Sex: Male
• Patient Weight: 14 KG