FDA.reportPublic FDA data

MAUDE MDR 3476878

MDR report key
3476878
Report number
1625685-2013-00088
Event key
0
Event type
3
Date of event
2013-07-24
Date received
2013-11-19
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 PLEURAL EFFUSIONSHUNT, PERITONEALCAREFUSIONKPM42-90000000564183R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-190

Event Narratives#

D

Patient 1

THE?DISTRIBUTOR REPORTED THAT DURING INCOMING INSPECTION, THE FOLLOWING WAS FOUND:?A FOREIGN FIBER BIGGER THAN TAPPI 0.8 ON THE PLEURAL CATHETER.

N

Patient 1

(B)(4). IN RESPONSE TO AN FDA INSPECTION, 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 OF CATALOG CODE (B)(4), LOT NUMBER 0000564183, WAS SUBMITTED FOR EVALUATION. EXAMINATION OF THE COMPLAINT SAMPLE CONFIRMED THE PRESENCE OF BLACK LOOSE DEBRIS AND WHITE LOOSE DEBRIS ON THE FENESTRATED PORTION OF THE TUBING WHICH COMBINED IS LARGER THAN 0.8 MM2 TAPPI. A REVIEW OF THE MANUFACTURING WORK INSTRUCTIONS FOR THE ASCITES DOUBLE VALVE SHUNT ASSEMBLY NOTED THE INSPECTION OF THE ASSEMBLY IS A VISUAL INSPECTION PROCESS. THE WORK INSTRUCTIONS INCLUDE SEVERAL INDICATIONS ENSURING THE OPERATOR INSPECTS THE SEALED TRAYS ADEQUATELY. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND INSPECTION METHODS IDENTIFIED SPECIFIC MANUFACTURING AND INSPECTION STEPS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE CONTRIBUTION OF THESE MANUFACTURING AND INSPECTION STEPS WILL BE EVALUATED IN CAPA INVESTIGATION IS (B)(4). IN ADDITION, A REVIEW OF ALL MATERIALS USED IN THE ASSEMBLY OF THE ASCITES DOUBLE VALVE SHUNT ASSEMBLY IDENTIFIED SPECIFIC COMPONENTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE CONTRIBUTION OF THESE MATERIALS WILL ALSO BE EVALUATED IN THE CAPA INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR), RAW MATERIAL HISTORY FILES, AND STERILIZATION BATCH RECORDS FOR THE LISTED MANUFACTURING LOT SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE FOLLOWING ARE THE MOST PROBABLE ROOT CAUSES: SOME MATERIAL TRANSFER METHODS WERE NOT PROPERLY DEFINED. SEVERAL SOURCES OF DEBRIS EXISTED FROM THE MANUFACTURING PROCESS. PHYSICAL PROPERTY OF SOME OF THE MATERIALS USED FOR MANUFACTURE OF THE PRODUCT, GENERATED STATIC WHICH PROMOTES DEBRIS TO BECOME ATTACHED ONTO THE COMPONENTS CONTAINED IN THE FINISHED GOOD TRAYS. SOME RAW MATERIALS WERE BEING SUPPLIED WITH DEBRIS AS WELL AS SOME FINISHED GOOD COMPONENTS. THERE WERE UNDEFINED SPECIFICATIONS FOR DEBRIS BETWEEN CAREFUSION AND RAW MATERIAL SUPPLIERS. CAREFUSION PERSONNEL WERE NOT FOLLOWING MANUFACTURING PROCEDURES PROPERLY. THE INTERNAL CAPA INVESTIGATION IS UNDER EXECUTION TO ADDRESS THIS FAILURE MODE. ALL CORRECTIVE AND PREVENTIVE ACTIONS (INCLUDING MANUFACTURING AND QUALITY PLAN IMPROVEMENTS) WILL BE IMPLEMENTED PER THE CAPA. IN ADDITION, PREVENTIVE ACTIONS INCLUDE, BUT ARE NOT LIMITED TO, DEVELOPING DEBRIS STANDARDS ACCORDING TO CURRENT INDUSTRY REQUIREMENTS.