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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	10/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Berlin heart was notified on (b)(6) 2022, that on (b)(6) 2022, the patient exhibited left-sided weakness, and asymmetry of the face.A head ct and cta of the head and neck were obtained, showing a rmca embolic stroke.The patient underwent at a successful thrombectomy and is recovering in the icu.The site reported that the patient is moving all extremities and has had a full neurological recovery.The site also reported that at the time of the event, thrombin was noted in the metal connector on the outflow 6-9 connecting set.Two pump "clean-outs" were performed to remove the fibrin.The ecxor blood pump continued to function as expected, with complete filling and emptying.
Additional Manufacturer Narrative
The lvad pump where the deposits were seen (b)(4), was in use for 32 days at the time of the event (from (b)(6) 2022 to (b)(6) 2022).We have reviewed the production records of the excor blood pump, s/n (b)(4), this pump was produced according to our specification.The patient returned to neurological baseline following the thrombectomy, thus the ae was resolved at the time of reporting.

• 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: 15676813
• Report Number: 3004582654-2022-00039
• Device Sequence Number: 17747820
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

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: 09/30/2024
• 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: 10/03/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 23 MO
• Patient Sex: Male
• Patient Weight: 10 KG