FDA Adverse Event Other Summary report: N

DIDECO LILIPUT ECMO M PHISIO

MDR report key: 2550724 · Received April 20, 2012

Report

Report Number: 1718850-2012-00043
Event Type: Other
Date Received: April 20, 2012
Date of Event: March 10, 2012
Report Date: March 22, 2012
Manufacturer: SORIN GROUP ITALIA
Product Code: DTZ
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE LILLIPUT ECMO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE LILLIPUT ECMO IS NOT SOLD IN THE UNITED STATES. HOWEVER, THE D901 LILLIPUT OXYGENATOR IS DISTRIBUTED IN THE UNITED STATES. THE TEMPERATURE PROBE WELL IS COMMON BETWEEN BOTH DEVICES. THIS MEDWATCH IS BEING FILED FOR THIS REASON. THE 510(K) NUMBER FOR THE D902 LILLIPUT OXYGENATOR IS K013915. SORIN GROUP (B)(4) RECEIVED A REPORT OF A LILLIPUT ECMO OXYGENATOR THAT LEAKED FROM THE TEMPERATURE PROBE WELL JUST PRIOR TO INITIATING ECMO. THE OXYGENATOR WAS CHANGED OUT. CARDIAC MASSAGE WAS PERFORMED WHILE THE DEVICE WAS CHANGED OUT. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE,

Description of Event or Problem · 1

SORIN GROUP (B)(4) RECEIVED A REPORT OF A LILLIPUT ECMO OXYGENATOR THAT LEAKED FROM THE TEMPERATURE PROBE WELL JUST PRIOR TO INITIATING ECMO. THE OXYGENATOR WAS CHANGED OUT. CARDIAC MASSAGE WAS PERFORMED WHILE THE DEVICE WAS CHANGED OUT. THERE WAS NO REPORT OF PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DIDECO LILIPUT ECMO M PHISIO	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	SORIN GROUP ITALIA	NA	1105310097

Patients

Seq	Age	Sex	Outcome	Treatment
1	NP