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	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n: (b)(6) on the patient since on (b)(6) 2024 until the time of the event on 2024-02-22 (14 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 on (b)(6) 2024, a pump change was performed due to hemolyis and squeaking at the valves, louder at the outflow than the inflow valve.The patient's ldh level increased from 1853 on (b)(6) 2024 to 2494 on (b)(6) 2024.According to the site, the pump maintained full fill and ejection and functioned as intended.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), was in use on the patient until the pump exchange (14 days).On 2024-03-07 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 could be detected.The blood pump was tested for functional performance.Both the parameters from the clinic, as well as the parameters used for pump release during production have been taken into consideration.The pump performance met our specifications.The pump was completely filling and emptying.During the evaluation, a noise was detected emanating from the blood pump.In addition to the typical pump noise, a distinct "squeaking" sound could also be heard at the outflow valve of the blood pump.A slight vibration of the leaflets was detected.The analysis of the valve leaflets showed no defects.Squeaking noises were confirmed during evaluation.The valves were tested during production at berlin heart gmbh and no abnormalities were found.During operation on patients, a squeaking noise can sometimes occur from the pu valves.This effect only occurs in a valve-dependent pressure range in the pump valve junction.The pressure at the valve is strongly dependent on the patient's circular system, the implanted cannulas and the patient's blood properties.Therefore, the squeaking may start or stop when the drive parameters are changed or the patient's mobility changes.In this case, the reported squeaking noise at the valves could be reproduced during the analysis.A slight vibration of the valve leaflets was detected.Therefore, a correlation between the pump and the patient's elevated hemolysis cannot be excluded.Appropriate measures were implemented by the pump manufacturer, berlin heart gmbh.This pump was manufactured before the implementation of corrective action measures.

• 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: 18842044
• Report Number: 3004582654-2024-00012
• Device Sequence Number: 7214586
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/18/2024

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: 02/28/2024
• Device Model Number: P30P-001
• Device Catalogue Number: P30P-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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: 19 MO
• Patient Sex: Male
• Patient Weight: 11 KG