FDA Adverse Event Injury Summary report: N

BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

MDR report key: 17633098 · Received August 28, 2023

Report

Report Number: 3008454189-2023-00013
Event Type: Injury
Date Received: August 28, 2023
Date of Event: August 13, 2023
Report Date: August 28, 2023
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040157
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CO, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE EXCOR BLOOD PUMP, S/N, (B)(6) ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2023 UNTIL (B)(6) 2023 (82 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6), THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. ON (B)(6) 2023 THE PUMP WAS CHANGED FOR UPSIZING TO PROVIDE MORE CARDIAC OUTPUT.

Description of Event or Problem · 0

BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2023 THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM HAD ELEVATED LDH LEVEL, 987. ON (B)(6) 2023 AND 1436 ON (B)(6) 2023. THE UPPER LIMIT OF NORMAL FOR THE SITE IS 409. THE SITE REPORTED THAT THE PATIENT DID NOT SHOW ANY CLINICAL SIGNS OF HEMOLYSIS AND THAT THE BILIRUBIN LEVELS WERE STABLE. THE BERLIN HEART EXCOR PUMP FUNCTIONED AS EXPECTED WITH COMPLETE FILLING AND EJECTION, AND NO ABNORMAL NOISES WERE REPORTED FROM THE PUMP. OF NOTE, THE PATIENT WAS TRANSFERRED TO CICU ON (B)(6) 2023 FOR INCREASING RESPIRATORY SUPPORT AND INITIATION OF DIURETICS. STARTED ON MILRINONE DRIP ON (B)(6) 2023 AND EPI DRIP ON (B)(6) 2023. PATIENT WAS INTUBATED ON (B)(6) 2023 DUE TO RESPIRATORY DISTRESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1338370	BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM	VENTRICULAR ASSIST DEVICE	DSQ	BERLIN HEART GMBH	P15P-001		04260090040157

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR	Female	Other