FDA Adverse Event Malfunction Summary report: N

D901 LILLIPUT OXYGENATOR

MDR report key: 12621912 · Received October 13, 2021

Report

Report Number: 9680841-2021-00027
Event Type: Malfunction
Date Received: October 13, 2021
Date of Event: September 14, 2021
Report Date: October 12, 2021
Manufacturer: SORIN GROUP ITALIA
Product Code: DTZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D901 DIDECO LILLIPUT PHISIO OXYGENATOR (CATALOG NUMBER 05319, LOT 2011090114) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 05319 IS SIMILAR TO THE COMPLAINED D901 DIDECO LILLIPUT PHISIO OXYGENATOR ITEM 05316, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 05319 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE D901 DIDECO LILLIPUT PHISIO OXYGENATOR ITEM 05316, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K953835). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE D901 DIDECO LILLIPUT PHISIO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS NOT BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE D901 DIDECO LILLIPUT PHISIO OXYGENATOR WAS LEAKING. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1519932	D901 LILLIPUT OXYGENATOR	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	SORIN GROUP ITALIA		2011090114

Patients

Seq	Age	Sex	Outcome	Treatment
1