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	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The site contacted berlin heart, inc on (b)(6) 2022 to report that a patient supported in the lvad configuration had developed hemolysis and was planning a pump change.The ldh levels were as follows: baseline 853 ((b)(6) 2021); 1362 ((b)(6) 2021); 1263 ((b)(6) 2021); 1253 ((b)(6) 2021); 2056 ((b)(6) 2021); 1429 ((b)(6) 2021); 2365 ((b)(6) 2022), 4183 ((b)(6) 2022).The high end of ldh normal for the site is 334 for this patient's age.Of note: this patient's baseline has always been elevated due to liver failure secondary to a failing fontan physiology.The site also reported that there was a soft "chirp" that was audible at the outflow valve since (b)(6) 2021 and that goes away with slight pressure over the pu valve.However, the sound returns when the pressure is released.This chirp has been unchanged since (b)(6) 2021.The pump has been filling and ejecting completely, and no dimples or graphite dust have been noted.
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) 2021 until (b)(6) 2022 (103 days).

• 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: 13446386
• Report Number: 3008454189-2022-00003
• Device Sequence Number: 4328138
• Product Code: DSQ
• UDI-Device Identifier: 04260090040126
• UDI-Public: 04260090040126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2022
• Report Date (Section F): 02/03/2022

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: 05/31/2023
• Device Model Number: P30P-001X01
• Device Catalogue Number: P30P-001X01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/18/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2022
• 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: 7 YR
• Patient Sex: Male
• Patient Weight: 21 KG
• Date Report Sent to FDA: 02/03/2022