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

Model Number	P30P-001X01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6) was used on the patient from (b)(6) 2024 until the time of the event on 2024-03-19 (4 days).We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specification.The support was withdrawn from the patient due to poor prognosis.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted berlin heart inc.To report that the patient experienced acute neurological changes and subsequently suffered a cardiac arrest.During cpr, one of the nurses noted air bubbles resembling foam in the pump.On 3/21/24, the site reported that during the event, the left ventricle had emptied significantly and the pump was not filling, a decision was made to decrease the rate on the ikus driver and substitute volume.The air in the pump was no longer visible, and the pump began filling completely.The site also reported the presence of air in the right heart.It was also reported that the patient had a la line placed at the time of the implant.After further discussion with the site, the source of the air could not be determined.The site also reported that there was nothing unusual with the cannulas or pump/membrane that could potentially introduce air to the patient.
Additional Manufacturer Narrative
The patient support was withdrawn 2 days after the adverse event was reported, hence box b2 has been corrected from death to life threatening.
Additional Manufacturer Narrative
On 2024-04-22 the blood pump in question was returned to berlin heart gmbh for investigation.During visual inspection, no abnormalites were detected.The blood pump was cleaned and disinfected to test its functionality.The pump performance met the specifications.The pump was completely filling and emptying, and the membrane movement showed no abnormalities.The blood pump was then opened, and the individual membrane layers were examined.All three layers were intact and the graphite distribution was uniform without any gaps.The stabilization ring was without any defects.Neither a defect nor a malfunction could be detected.All examinations revealed no abnormalities.The blood pump met its specifications.Therefore, no correlation between the pump and the incident of the patient could be determined.

• 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: 19109994
• Report Number: 3004582654-2024-00022
• Device Sequence Number: 18069110
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 06/30/2026
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024; Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 04/18/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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: Life Threatening; Death
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 20 KG