FDA Adverse Event Injury Summary report: N

EXCOR®

MDR report key: 20599714 · Received November 4, 2024

Report

Report Number: 3008454189-2024-00021
Event Type: Injury
Date Received: November 4, 2024
Date of Event: September 11, 2024
Report Date: November 4, 2024
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040102
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: FL, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE EXCOR BLOOD PUMPS PU VALVES; 10 ML IN/OUT; Ø 6 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2024 UNTIL THE TIME OF THE EVENT ON (B)(6) 2024 FOR 2 DAYS. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, SN (B)(6) AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

Description of Event or Problem · 0

THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2024 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM DEVELOPED HEMOLYSIS. THE PATIENT'S LDH VALUE INCREASED FROM 781 U/L ON (B)(6) 2024 TO 2530 U/L. THE PFHGB INCREASED FROM 60 MG/DL ON (B)(6) 2024 TO 270 MG/DL ON (B)(6)2024; AND THEN DECREASED TO 140 MG/DL ON (B)(6)2024. THE SITE'S LDH UPPER LIMIT OF NORMAL IS 225 U/L, AND PFHGB NORMAL IS <150 MG/DL.THE SITE IS CONTINUING TO MONITOR HEMOLYSIS LAB VALUES. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; SN (B)(6) PERFORMED AS INTENDED WITH COMPLETE FILL AND EJECTION. DEPOSITS WERE NOTED IN THE INFLOW VALVE OF THE EXCOR BLOOD PUMP ON (B)(6) 2024. THERE WERE NO ABNORMAL SOUNDS FROM THE PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2181163	EXCOR®	VENTRICULAR (ASSIST) BYPASS	DSQ	BERLIN HEART GMBH	P10P-001		04260090040102

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 DA	Female	Other