MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 60ML IN/OUT Ø 12MM; VENTRICULAR ASSIST DEVICE

Model Number	P60P-001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Berlin heart was informed by the clinic that excor mobile driving unit emitted an alarm about the pressure loss.A vad coordinator in the clinic detected a defect at the barb connector for the driving tube of the exco blood pump.The patient was clinically stable.The clinic changed the blood pump on (b)(6) 2023.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), was in use on the patient from 2022-06-15 until 2023-05-31 (350 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.
Additional Manufacturer Narrative
The excor blood pump, s/n (b)(6), is in use on the patient since 2022-06-15 (328 days).We have reviewed the production records of the excor blood pump s/n (b)(6).This pump was produced according to our specification.Upon receiving the blood pump for evaluation, it was observed that the affected blood pump had been returned with a partial driving tube connected to the blood pump connector.During this visual examination, it became evident that a piece of plastic tape had been placed around the blood pump connector.The pump was disinfected and cleaned.The plastic tape was thoroughly removed from the connector.Then the driving tube was demounted from the pump connector and the air chamber of the pump and the partial the driving tube was tested separately for leakage.No pressure drop was detected in both components.Therefore, it was determined that no defect in the pump connection or the returned part of the drive tube.Based on the test results, it was concluded that there were no defects present in either the pump connection or the returned part of the driving tube.It was unable to determine the exact cause for reported complaint.Therefore, it was possible that the driving tube may not have connected tight enough with the cable ties to cause the leakage.

• Brand Name: BLOOD PUMP PU VALVES 60ML IN/OUT Ø 12MM
• 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: 17038793
• Report Number: 3004582654-2023-00019
• Device Sequence Number: 15082015
• Product Code: DSQ
• UDI-Device Identifier: 04260090040027
• UDI-Public: 04260090040027
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 02/28/2023
• Device Model Number: P60P-001
• Device Catalogue Number: P60P-001
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2020
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 85 KG