FDA Adverse Event Injury Summary report: N

EXCOR®

MDR report key: 20791355 · Received November 27, 2024

Report

Report Number: 3008454189-2024-00025
Event Type: Injury
Date Received: November 27, 2024
Date of Event: November 8, 2024
Report Date: November 26, 2024
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040157
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: WI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE EXCOR BLOOD PUMPS PU VALVES; 15 ML IN/OUT; Ø 9 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2024 UNTIL THE TIME OF PUMP EXCHANGE ON (B)(6) 2024. THE PUMP WAS ON THE PATIENT FOR 49 DAYS, AND THE EVENT OCCURRED ON (B)(6) 2024 (45 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, (B)(6) AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE OTHER EVENT WHICH OCCURRED ON (B)(6) 2024 FROM THE SAME PUMP ASSOCIATED WITH THIS PATIENT WAS SUBMITTED AS 3004582654-2024-00058.

Description of Event or Problem · 0

ON (B)(6) 2024 THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT THAT THE PATIENT BECAME VERY IRRITABLE WITH RIGHT SIDE FLACCIDNESS ALONG WITH LEFT EYE GAZE ON (B)(6) 2024. HEAD AND NECK CT SCANS WERE PERFORMED 3 DAYS IN A ROW. THE RESULTS SHOWED THAT CONTINUED EVOLUTION OF THE LEFT MCA TERRITORY INFARCT WITH INCREASING ASSOCIATED EDEMA RESULTING IN WORSENING MASS EFFECT ON THE LEFT LATERAL VENTRICLE AS DETAILED. NO HEMORRHAGIC CONVERSION OR FRANK HERNIATION. ACCORDING TO THE SITE, THE BERLIN HEART EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM FUNCTIONED AS INTENDED, WITH COMPLETE FILL AND EJECTION. DEPOSITS WERE NOTED IN THE PUMP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
851390	EXCOR®	VENTRICULAR (ASSIST) BYPASS	DSQ	BERLIN HEART GMBH	P15P-001		04260090040157

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 MO	Female	Other