FDA.reportPublic FDA data

MAUDE MDR 3472781

MDR report key
3472781
Report number
1625685-2013-00051
Event key
0
Event type
3
Date of event
2013-03-19
Date received
2013-11-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JILL RITTORNO
Address
75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US
Phone
847-847-8473
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHUNT DENVER ASCITES PAK DOUBLE VALVESHUNT, PERITONEALCAREFUSIONKPM42-20500000515830R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-150

Event Narratives#

D

Patient 1

THE?DISTRIBUTOR REPORTED THAT DURING INCOMING INSPECTION, THE FOLLOWING WAS FOUND: THERE IS A BLACK STAIN ON THE INNER WALL OF THE PUMP CHAMBER.

N

Patient 1

(B)(4). IN RESPONSE TO AN FDA INSPECTION (B)(4) CAREFUSION 2200 INITIATED A CAPA INVESTIGATION (CAPA (B)(4)). AS PART OF THE CAPA, A RETROSPECTIVE REVIEW OF THE COMPLAINTS FOR ?DEBRIS? AND ?CONTAMINATION? FOR APPLICABLE DEVICES WAS CONDUCTED. IT WAS DETERMINED THAT THIS REPORT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORT (MDR). EVALUATION SUMMARY: ONE (1) UNOPENED SAMPLE WAS PROVIDED FOR EVALUATION. EVALUATION OF THE COMPLAINT SAMPLE DID NOT CONFIRM THE DEFECT REPORTED BY THE CUSTOMER. THE INVESTIGATION NOTED THE PRESENCE OF AN IMBEDDED PARTICLE ON THE BACK WALL OF THE PUMP CHAMBER THAT IS SMALLER THAN THE ESTABLISHED 0.8 TAPPI STANDARD FOR DEBRIS IN THE QUALITY PLAN FOR THIS PRODUCT CODE. IT HAS BEEN IDENTIFIED THAT THIS FAILURE MODE IS NOT AN ISOLATED EVENT. THE SHUNT ASSEMBLIES ARE MANUFACTURED IN A CONTROLLED MANUFACTURING ENVIRONMENT THAT USES STRICT CONTROL OVER PRODUCT MOVEMENT INTO AND OUT OF THE MANUFACTURING ROOM AND REQUIRES SPECIALTY PERSONAL PROTECTIVE EQUIPMENT FOR THE MANUFACTURING PERSONNEL TO MINIMIZE THE INADVERTENT TRANSFER OF DEBRIS. A DEVICE HISTORY REVIEW (DHR) FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE FOR THE DEBRIS SMALLER THAN THE TAPPI STANDARD WAS IDENTIFIED AS DEBRIS TRANSFER DURING THE MANUFACTURE OF THE PRODUCT. THE MANUFACTURING PLANT HAS ALSO INITIATED A CAPA INVESTIGATION (B)(4) TO ADDRESS THE REPORTED ISSUE. ALL CORRECTIVE AND PREVENTIVE ACTIONS (INCLUDING MANUFACTURING AND QUALITY PLAN IMPROVEMENTS) WILL BE IMPLEMENTED PER THE CAPA.