FDA Adverse Event Malfunction Summary report: N

S3 ROLLER PUMP MODULE AND CONSOLE

MDR report key: 1645279 · Received March 24, 2010

Report

Report Number: 1718850-2010-00049
Event Type: Malfunction
Date Received: March 24, 2010
Date of Event: August 13, 2007
Report Date: August 27, 2007
Manufacturer: SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR
Product Code: DTQ
PMA / PMN Number: K950990
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B) (4) MANUFACTURES THE S3 ROLLER PUMP MODULE AND CONSOLE. THE CONTROL DISPLAY MODULE IS A COMPONENT OF THIS SYSTEM. THE 510(K) NUMBER FOR THE S3 ROLLER PUMP MODULE AND CONSOLE IS K950990. THE INCIDENT OCCURRED AT (B) (6) HOSPITAL IN (B) (6). THIS MEDWATCH REPORT IS FILED BY SORIN GROUP (B) (4) ON BEHALF OF SORIN GROUP (B) (4). (B) (4) THE PERFUSIONIST REPORTED THAT MOST OF THE HOLDERS OF THE CIRCUIT BOARD IN THE CONTROL DISPLAY MODULE (CDM) ARE BROKEN. THE PERFUSIONIST FURTHER ALLEGES THAT THIS MODULE WAS LIKELY CAUSE FOR THE STOPPAGE OF THE ARTERIAL PUMP DURING A CASE. THE CDM WAS REPLACED. THE MODULE WAS RETURNED TO SORIN GROUP (B) (4) FOR EVALUATION, WHERE THE HOLDER BREAKAGE WAS CONFIRMED. THE CAUSE OF THE FAILURE WAS THE MATERIAL USE FOR THE HOLDERS, WHICH WAS REPLACED WITH A MORE APPROPRIATE MATERIAL.

Description of Event or Problem · 1

THE PERFUSIONIST REPORTED THAT MOST OF THE HOLDERS OF THE CIRCUIT BOARD IN THE CONTROL DISPLAY MODULE (CDM) ARE BROKEN. THE PERFUSIONIST FURTHER ALLEGES THAT THIS MODULE WAS THE LIKELY CAUSE FOR THE STOPPAGE OF THE ARTERIAL PUMP DURING A CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	S3 ROLLER PUMP MODULE AND CONSOLE	CARDIOPULMONARY BYPASS CONSOLE, HEART-LUNG MACHINE	DTQ	SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1