FDA Adverse Event Injury Summary report: N

BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM

MDR report key: 13446386 · Received February 3, 2022

Report

Report Number: 3008454189-2022-00003
Event Type: Injury
Date Received: February 3, 2022
Date of Event: January 18, 2022
Report Date: February 3, 2022
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040126
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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).

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1175615	BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM	VENTRICULAR ASSIST DEVICE	DSQ	BERLIN HEART GMBH	P30P-001X01		04260090040126

Patients

Seq	Age	Sex	Outcome	Treatment
1	7 YR	Male	Other