1423500-2010-03615

Report

Report Number: 1423500-2010-03615
Date Received: September 22, 2010
Product Code: FKX
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE HOMECHOICE DEVICE WILL BE RELEASED TO BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. UPON COMPLETION OF THE EVALUATION A FOLLOW UP REPORT WILL BE SUBMITTED. CURRENTLY, THE CORONER'S OFFICE HAS RETAINED THE SAMPLE OF THE TUBING FOUND AT THE PATIENT'S HOME. A REQUEST HAS BEEN MADE FOR RETURN OF THE SAMPLE TO THE BAXTER PRODUCT ANALYSIS LAB UPON COMPLETION OF THE CORONER'S INVESTIGATION. SHOULD THE SAMPLE BE RECEIVED AND AN EVALUATION BE COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN, THEREFORE THE 510K NUMBER HAS BEEN LEFT BLANK.

Additional Manufacturer Narrative · 1

(B)(4). THE COMPLAINT EVENT OF PATIENT DEATH DUE TO ASPHYXIA CAUSED BY STRANGULATION BY A BAXTER APD SET TUBING WAS CONFIRMED THROUGH SCENE PHOTOS AND THE AUTOPSY REPORT. NO PRODUCT DEFECTS OR FAILURES WERE REPORTED CONTRIBUTING TO THE EVENT. THE HOMECHOICE PRO CYCLER CAN DETECT RESTRICTED FLOW DURING THERAPY, RAISE AUDIO/VISUAL ALERTS AND HALT THE THERAPY UNTIL THE PROBLEM IS CORRECTED. THE EVALUATION OF THE HOMECHOICE INSTRUMENT REVEALED THAT THE PATIENT WAS NOT PERFORMING THERAPY AT THE TIME OF DEATH PER THE DEATH CERTIFICATE. THEREFORE, NO FLOW WAS PRESENT AND THE INSTRUMENT WOULD NOT DETECT A COLLAPSED OR KINKED TUBE IF ONE HAD BEEN PRESENT. THE FINAL TREATMENT PRIOR TO THE PATIENT'S DEATH WAS COMPLETED ON (B)(6) 2010 AT 05:47:53 IN THE MORNING. THE INSTRUMENT PASSED ALL REQUIRED TESTING. A TREND REVIEW REVEALED THERE HAVE BEEN NO SIMILAR EVENTS OF PATIENT DEATH DUE TO STRANGULATION BY A BAXTER RENAL PRODUCT REPORTED TO BAXTER BETWEEN (B)(6) 2001 AND (B)(6) 2010. BASED ON INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, IT IS POSSIBLE THAT A SEIZURE CONTRIBUTED TO THE PATIENT'S INABILITY TO FREE HIMSELF FROM THE TUBING. BAXTER HAS ISSUED A SAFETY ALERT LETTER TO RENAL CUSTOMERS DATED 3/15/2011 ALERTING THEM OF SAFEGUARDS THAT SHOULD BE CONSIDERED WITH SEIZURE PRONE AND OTHER AT-RISK PATIENTS. THE SAFETY ALERT LETTER IS ATTACHED TO THIS MEDWATCH. BAXTER HAS CONDUCTED A TREND REVIEW FROM (B)(6) 2001 THROUGH (B)(6) 2010 WHICH REVEALED NO SIMILAR REPORTS HAVE BEEN RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). A COPY OF THE AUTOPSY REPORT AND INVESTIGATOR'S REPORT WAS RECEIVED FROM THE (B)(6) COUNTY CORONER'S OFFICE, SAN ANTONIO, TEXAS. THE FINDINGS OF THE AUTOPSY REPORT CONCLUDED: "IT IS OUR OPINION THAT THE DESCENDENT, (B)(6), A (B)(6) OLD MAN, DIED AS A RESULT OF ASPHYXIA BY LIGATURE STRANGULATION, WITH CONGENITAL RENAL DYSPLASIA CONTRIBUTING TO THE CAUSE OF DEATH. THE DECEDENT WAS ON LIFE LONG DIALYSIS TREATMENT DUE TO THE KIDNEY ABNORMALITY, AND DURING SLEEP, BECAME ENTANGLED IN THE DIALYSIS TUBING, CAUSING STRANGULATION. THE POSSIBILITY THAT A SEIZURE CONTRIBUTED TO HIS POSITIONING CANNOT BE RULED OUT. MANNER OF DEATH: ACCIDENT" THE TUBING WILL NOT BE RELEASED TO BAXTER FOR EVALUATION.

Description of Event or Problem · 1

DURING AN ENDOSCOPIC SINUS PROCEDURE THE BUR BROKE. THE BUR TIP WAS EASILY REMOVED FROM THE SURGICAL SITE AND IRRIGATION WAS USED TO INSURE NO RESIDUAL DEBRIS REMAINED. THE SURGERY PROCEEDED AS INTENDED WITHOUT ANY SIGNIFICANT DELAY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION WITH NO ADVERSE PATIENT CONSEQUENCES, COMPLICATIONS, OR SEQUELA AS A RESULT OF THIS EVENT. ALL PORTIONS OF THE BROKEN BLADE WERE RETURNED, INDICATING THAT NO UNRETRIEVED DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE TIP THAT SEPARATED FROM THE SHAFT MEASURED APPROXIMATELY 1 INCH. THE BREAK POINTS INCLUDED THE INNER AND OUTER SPIRAL WRAP. VISUAL INSPECTION OF THE HUBS SHOWED INDENTS IN THE LOCKING AREA OF THE OUTER HUB CAUSED BY THE HANDPIECE LOCKING MECHANISM AND DAMAGE TO THE INNER HUB CHEVRON TIPS. VISUAL INSPECTION OF THE OUTER TUBE SUPPORT AREA FOR THE TIP SHOWED GOUGES AND FLARING OF THE OUTSIDE DIAMETER. THE GOUGES ON THE OUTER TUBE CORRESPOND TO MARKS ON THE TIP. THE DAMAGE TO THE BUR INDICATES EXCESSIVE PRESSURE WAS APPLIED TO THE BUR. FUNCTIONAL INSPECTION SHOWS THAT THE BUR LOADS PROPERLY INTO THE HAND PIECE. PRODUCT IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: "EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT."

Description of Event or Problem · 1

INFORMATION RECEIVED BY (B)(4) ON 09/02/10 REGARDING THE PATIENT EXPIRATION. GLOBAL PHARMACOVIGILANCE PROVIDED THE FOLLOWING INFORMATION ON 09/10/10 INDICATING A (B)(6) MALE PATIENT WAS FOUND DEAD AT HIS RESIDENCY ON (B)(6) 2010. THE AUTOPSY REPORT INDICATES DEATH WAS RELATED TO ACCIDENTAL ASPHYXIA DUE TO "RIGATURE": (LIGATURE) STRANGULATION. SEIZURES HAVE NOT BEEN RULED OUT AS A POSSIBLE CAUSE OF DEATH. THE NURSE STATED DEATH WAS NOT RELATED TO DIANEAL SOLUTION, BUT MAY HAVE BEEN RELATED TO THE PD CATHETER AND LINE CONNECTED BETWEEN THE PATIENT AND THE HOMECHOICE PRO MACHINE. REPORTEDLY, IN (B)(6) 2010, THE PATIENT HAD EXPERIENCED A SEIZURE AND WAS TO FOLLOW UP WITH A NEUROLOGIST. IN (B)(6) 2010 (3 WEEKS PRIOR TO DEATH) THE PATIENT EXPERIENCED AN INCREASE IN HEADACHES. ON THE EVENING OF (B)(6) 2010, THE PATIENT PERFORMED PD THERAPY. ON (B)(6) 2010, THE PATIENT WAS FOUND DEAD IN HIS HOME (EXACT TIME OF DEATH WAS UNKNOWN). THE NURSE WAS UNABLE TO CONFIRM IF THE PATIENT WAS STILL HOOKED UP TO THE HOMECHOICE PRO MACHINE AT THE TIME OF DEATH, BUT THE PATIENT HAD COMPLETED THERAPY. THE NURSE STATED THE HEADACHES HAD NEVER RESOLVED AND THE DIAGNOSIS OF SEIZURES WAS NEVER CONFIRMED. THE PATIENT WAS NOT HOSPITALIZED PRIOR TO OR AT THE TIME OF DEATH. IN (B)(6) 2010, THE PATIENT FELL ON THE FLOOR AND WAS HOSPITALIZED. THE PATIENT'S MOTHER BELIEVED THE PATIENT HAD A SEIZURE, BUT A COMPUTED AXIAL TOMOGRAPHY (CT) SCAN AND MAGNETIC RESONANCE IMAGING (MRI) WERE NORMAL AND SHOWED NO SEIZURE ACTIVITY. DURING THIS HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH HYPERTENSION. THE SYSTOLIC BLOOD PRESSURE WAS IN THE "190S TO 200S". DURING HOSPITALIZATION, THE PATIENT WAS STARTED ON AN UNKNOWN BLOOD PRESSURE MEDICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1			FKX

Patients

Seq	Age	Sex	Outcome	Treatment
1