MAUDE Adverse Event Report: BERLIN HEART GMBH BLOOD PUMP PU VALVES 50 ML, IN/OUT 12 MM; VENTRICULAR ASSIST DEVICE

Model Number	P50P-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump, 1820629, is still in use on the patient and was in use for 29 day at the time of the event (from (b)(6) 2021 to (b)(6) 2021).
Event or Problem Description
We were informed by the clinic that a patient had an adverse event on (b)(6) 2021 the clinic reported that the patient suffered from an ischemic cva.The patient had an infarction in the medial cerebral artery 4 weeks ago.Without any symptoms or physiological dysfunction.On (b)(6) 2021 the patient showed apoplexy and was bleeding from the medial cerebral artery.Venous bleeding was stopped and ct confirmed.The patient was responsive, oriented and awake.There were deposits seen in the blood pump at the time of the event.

• Brand Name: BLOOD PUMP PU VALVES 50 ML, IN/OUT 12 MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 12029027
• Report Number: 3004582654-2021-00033
• Device Sequence Number: 4339577
• Product Code: DSQ
• UDI-Device Identifier: 04260090040010
• UDI-Public: 04260090040010
• 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): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 09/30/2023
• Device Model Number: P50P-001
• Device Catalogue Number: P50P-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR