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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The clinic contacted berlin heart to report that they had observed incomplete emptying consistently for the last 3 days prior to reporting.An obstruction of the outflow cannula was ruled out by a ct-scan of the chest.The systole value was increased to 200 on the driving unit with very little effect.The patient was reported to remain stable and well supported at the time of the report.The site then decided to exchange the blood pump due to concern for inability to fully eject.After the pump exchange on (b)(6) 2022, full emptying was observed with the systole value returned to 180.
Additional Manufacturer Narrative
The excor blood pump, s/n, (b)(4) on the patient at the time of the event was in use from (b)(6) 2022 until (b)(6) 2022 (128 days).We have reviewed the production records of the excor blood pump.This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
No abnormalities were detected upon initial visual examination of the returned blood pump.No air pillow was observed.The blood pump was tested for functional performance using the driving unit settings at the time of the event reported by the site and repeated the test using different parameters defined in internal procedures.The pump's performance was within specification for both the testing parameters defined by berlin heart and the clinic's settings.The pump showed complete filling and ejection.For further analysis, the blood pump was disassembled, and the membrane layers were examined individually.All three membrane layers were intact and showed no defect.The dispersion of graphite was uniform and gapless.Neither a defect, nor a functional impairment was detected.The blood pump met its specification.Unable to determine the cause for the reported incomplete emptying.

• 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, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 15497593
• Report Number: 3004582654-2022-00036
• Device Sequence Number: 20356006
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 10/31/2024
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 34 KG