FDA Adverse Event Other Summary report: N

D903 DIDECO AVANT VAVD PHISIO

MDR report key: 3299741 · Received August 16, 2013

Report

Report Number: 1718850-2013-00178
Event Type: Other
Date Received: August 16, 2013
Date of Event: July 19, 2013
Report Date: July 22, 2013
Manufacturer: SORIN GROUP ITALIA
Product Code: DTZ
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE D903 DIDECO AVANT VAVD PHISIO OXYGENATOR WHICH IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO THE D903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING WHICH IS DISTRIBUTED IN THE UNITED STATES. THE 510(K) NUMBER FOR THE D903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING IS K033323. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT AIR WAS DELIVERED TO THE RIGHT SECTION OF THE PATIENT'S HEART DURING A PROCEDURE. ALTHOUGH NO MALFUNCTION OF A SORIN DEVICE HAS BEEN IDENTIFIED, A SORIN AVANT OXYGENATOR WAS BEING USED FOR THE PROCEDURE. THE PATIENT EXPIRED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

SORIN GROUP (B)(4) RECEIVED A REPORT THAT AIR WAS DELIVERED TO THE RIGHT SECTION OF THE PATIENT'S HEART DURING A PROCEDURE. ALTHOUGH NO MALFUNCTION OF A SORIN DEVICE HAS BEEN IDENTIFIED, A SORIN AVANT OXYGENATOR WAS BEING USED FOR THE PROCEDURE. THE PATIENT EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
397127	D903 DIDECO AVANT VAVD PHISIO	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	SORIN GROUP ITALIA	NA	1304160015

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Death