FDA Adverse Event Other Summary report: N

3-TO-1 REDUCTION DRIVE

MDR report key: 2389341 · Received December 14, 2011

Report

Report Number: 1718850-2011-00150
Event Type: Other
Date Received: December 14, 2011
Date of Event: May 25, 2010
Report Date: August 26, 2011
Manufacturer: SORIN GROUP DEUTSCHMAND
Product Code: DTQ
PMA / PMN Number: K950990
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE S3 ROLLER PUMP (510(K) NUMBER K950990) AND THE S3 DOUBLE HEADED ROLLER PUMP (510(K) NUMBER K955038). THE SPEED POTENTIOMETER IS A COMPONENT OF THESE PUMPS. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4)'S MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP (B)(4) RECEIVED A COMPLAINT THAT THE PUMP STOPPED SEVERAL TIMES AT A SPECIFIC PUMP SPEED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS DETERMINED THAT THE SPEED POTENTIOMETER WAS DEFECTIVE AND IT WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER ANALYSIS. DEBRIS WAS FOUND INSIDE THE SPEED POTENTIOMETER. SORIN GROUP (B)(4) STATED THAT THE DEBRIS CAUSED THE REPORTED PROBLEM. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR SIMILAR ISSUES. NO FURTHER ACTION IS REQUIRED. ADDITIONAL 510(K)#: K955038.

Description of Event or Problem · 1

SORIN GROUP (B)(4) RECEIVED A COMPLAINT THAT THE PUMP STOPPED SEVERAL TIMES AT A SPECIFIC PUMP SPEED. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	3-TO-1 REDUCTION DRIVE	SPEED POTENTIOMETER	DTQ	SORIN GROUP DEUTSCHMAND	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1