FDA Adverse Event Injury Summary report: N

BERLIN HEART EXCOR PEDIATRIC VAD

MDR report key: 7318509 · Received March 6, 2018

Report

Report Number: 3004582654-2018-00010
Event Type: Injury
Date Received: March 6, 2018
Date of Event: February 6, 2018
Report Date: March 5, 2018
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
PMA / PMN Number: P160035
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). THE ADVERSE EVENT IS RELATED TO A RE-OPENED TRACHEA WOUND, WHICH THE PATIENT SUFFERED PRIOR TO EXCOR IMPLANTATION. THE PATIENT REMAINS ON SUPPORT. BASED ON CURRENT INFORMATION, IT APPEARS TO BE USER ERROR. G8: ADVERSE EVENT TERM: AIR EMBOLISM.

Description of Event or Problem · 0

BERLIN HEART WAS INFORMED BY THE CLINIC ON (B)(6) 2018 THAT A PATIENT IMPLANTED IN THE LVAD CONFIGURATION HAD AIR IN THE BLOOD CHAMBER OF THE BLOOD PUMP. THE CLINIC USED THE PUMPS DE-AIRING TOOL TO GET THE AIR OUT OF THE BLOOD SIDE LAYER. BEFORE EXCOR WAS IMPLANTED THE PATIENT SUFFERED A TRACHEA WOUND FROM INTUBATION WHICH ALREADY LED TO EMBOLISM ONCE. THAT TRACHEA WOUND DID OPEN AGAIN, WHICH LED TO THE AIR IN THE BLOOD CHAMBER OF THE PUMP. THE SITE STATED THAT A "PROBLEM WITH THE LUNG CIRCULATION AND COMPLICATION DURING RE-INTUBATION" WAS RESPONSIBLE FOR THE EVENT AND THERE WAS "NO PROBLEM WITH THE BLOOD PUMP". THE DEVICE PERFORMED AS DESIGNED ASIDE FROM SLIGHT FILLING DIFFICULTIES DUE TO THE AIR PRESENT IN THE BLOOD CHAMBER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
159438	BERLIN HEART EXCOR PEDIATRIC VAD	VENTRICULAR ASSIST DEVICE	DSQ	BERLIN HEART GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	9 YR		Life Threatening