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	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor blood pump s/n (b)(6) was in use on the patient from (b)(6) 2023 until the time of the event on 2024-01-17 (145 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
Berlin heart clinical affairs was informed that the clinic noted suspected pillow of the blood pump membrane.The clinic had exchanged the blood pump.
Additional Manufacturer Narrative
The excor blood pump, s/n: (b)(6), was in use on the patient until the pump exchange (145 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 2024-01-25.During external visual inspection of the returned blood pump, no abnormalities were found.No pillows were observed as reported.The blood pump was tested for functional performance.The pump performance met the specifications.The pump was completely filling and emptying, and the membrane movement showed no abnormalities.For internal inspection, the blood pump was disassembled, and the individual membrane layers were examined.All three layers of the membrane were intact and the graphite distribution was uniform without any gaps.The stabilizing ring was without any defects.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 25 ML, IN/OUT Ø9 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 18558867
• Report Number: 3004582654-2024-00005
• Device Sequence Number: 6383455
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 04/30/2025
• Device Model Number: P25P-001
• Device Catalogue Number: P25P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 4 KG