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	Hemolysis (1886)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
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 (15 days).We have reviewed the production records of the excor blood pump, s/n (b)(4).This pump was produced according to our specification.A detailed investigation report will be provided as soon as it is available.As of (b)(6) 2022 the patient's ldh level was 4000, showing no decrease after changing the pump on (b)(6) 2022.
Event or Problem Description
Site contacted berlin heart ca on 9.15.2022 to report that the patient had elevated ldh levels, and the pump was exchanged due to concerns for hemolysis.The following lab values were reported: (b)(6): plasma free hemoglobin - 235.(b)(6): ldh - 1383.(b)(6) ldh - 3900.Normal values for the site ldh 1383.Pump maintained completed fill and ejection.Site reported there were neither acoustic nor visual abnormalities associated with the blood pump.In addition, there are no deposits reported.

• 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
• MDR Report Key: 15498587
• Report Number: 3008454189-2022-00013
• Device Sequence Number: 14916930
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2022
• Report Date (Section F): 09/27/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2022
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2022
• 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: 23 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Date Report Sent to FDA: 09/27/2022