HOME CHOICE, INTERNATIONAL 220V
Report
- Report Number
- 1423500-2009-00588
- Event Type
- Death
- Date Received
- December 30, 2009
- Date of Event
- November 4, 2009
- Report Date
- November 5, 2009
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- FKX
- PMA / PMN Number
- K012988
- Removal / Correction Number
- 1423500-01/08/10-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
(B) (4). THERE IS AN ONGOING CAPA INVESTIGATION, (B) (4)-CAPA-(B) (4), ASSOCIATED WITH THIS REPORT.
(B) (4).
.
(B)(4). THE HOMECHOICE DESIGNER PROVIDED THE FOLLOWING ADDITIONAL EVALUATION OF THE DEVICE INVOLVED: THE DEVICE WAS SET TO THE (B)(4) LANGUAGE SETTING UPON POWER UP. THE DEVICE WAS THEN SWITCHED TO THE ENGLISH LANGUAGE SETTING AND THE EVENT LOG, CONFIGURATION FILE, AND THERAPY LOGS WERE ALL UPLOADED FROM THE DEVICE. THE DEVICE WAS THEN SET UP ON THE RETURNED INSTRUMENT TEST EVALUATION (RITE) TEST STAND AND WAS PROCESSED TWICE. EACH TEST RESULTED IN A PASS. THE LOG WAS THEN ANALYZED AND THE FOLLOWING KEY OBSERVATIONS WERE MADE: THERE WERE MULTIPLE LOW DRAIN ALARMS WITHIN THE LOG, THE INITIAL DRAIN WAS SET TO 1200, LESS THAN 70% OF THE LAST FILL VOLUME, THE DRAIN VOLUME PERCENTAGE WAS SET TO 70, THE DEVICE GENERATED A SYSTEM ERROR 2084 (ILLEGAL DOOR OPEN) ON THE MORNING OF (B)(6)2009, VARIOUS PUMP ERRORS WERE GENERATED INDICATING OCCLUDED SOURCE OR SOURCE ISSUES SUCH AS LACK OF FLUID, AND A LOW DRAIN CONDITION ON (B)(6)2009 WAS JUST ABOVE THE PATIENT'S MINIMUM DRAIN ALARM; THEREFORE, AN ALARM WAS NOT GENERATED. ON (B)(6)2009, THE INITIAL DRAIN ONLY REMOVED 1341 MILLILITERS (ML) OF 2000ML (PREVIOUS EVENING?S LAST FILL). THE DEVICE PROCEEDED TO FILL 1 BUT ALARMED LOW DRAIN DURING DRAIN 1 AFTER DRAINING 289ML OF 2399ML (PREVIOUS FILL 1). THE USER INTERACTED WITH THE DEVICE AND CONTINUED THERAPY. AFTER DRAINING 1694ML OF 2399ML (PREVIOUS FILL 1), DRAIN 1 ENDED DUE TO AIR DETECTION. THE DEVICE THEN COMPLETED FILL 2. DURING DWELL 2 THE THERAPY WAS TERMINATED. ACCORDING TO INFORMATION PROVIDED BY THE REPORTER, AN OFF-CYCLER DRAIN OF 4300ML WAS PERFORMED TWO DAYS LATER. BASED ON THE PATIENT'S FILL VOLUME OF 2400ML, THIS AMOUNT OF DRAIN REPRESENTS A 79% INCREASED INTRAPERITONEAL VOLUME (IIPV) CONDITION. THIS INSTANCE OF IIPV CAN BE ATTRIBUTED TO AN INAPPROPRIATE INITIAL DRAIN ALARM SETTING AND AN INAPPROPRIATE DRAIN VOLUME PERCENT SETTING (70) COUPLED WITH A PATIENT THAT APPEARS TO HAVE DIFFICULTY DRAINING. UPON EXAMINATION OF THE ALARM LOG, THE DEVICE HAD GENERATED LOW DRAIN ALARMS EACH AND EVERY DAY, STARTING ON (B)(6)2009 UNTIL THE DATE OF THE INCIDENT. THE DEVICE OPERATES AS EXPECTED AND SHOWS THE ABILITY TO PERFORM AND DELIVER FLUID ACCURATELY.
(B)(4). PRODUCT PROBLEM IS ALSO CHECKED FOR THE REPORT OF INCREASED INTRAPERITONEAL VOLUME (IIPV). THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING (B)(4)..
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ALL SEVEN TROCARS HAD EXCESSIVE LEAKAGE THROUGHOUT THE PROCEDURE. A SECOND INSUFFLATION MACHINE HAD TO BE BROUGHT INTO THE ROOM AND THE PRESSURE LEVEL WAS SENT HIGHER THAN NORMAL. THE PROCEDURE WAS PROLONGED FOR FIFTEEN MINUTES. THE SAME TROCARS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. SEVEN TROCARS WILL BE RETURNED.
CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) WITH ERRONEOUSLY ELEVATED TT4 RESULTS ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. UPON REPEAT THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.
THE SON OF THE PATIENT CONTACTED BAXTER AND CLAIMED THAT THE PATIENT'S CARDIAC ARREST WAS INDUCED BY EXCESSIVE INJECTION OF DIALYSATE OWING TO MACHINE'S DYSFUNCTION, BUT THE EXACT CAUSE OF CARDIAC ARREST IS STILL UNKNOWN. DURING AUTOMATED PERITONEAL DIALYSIS (APD) IN 2009 AT 2:30AM, THE PATIENT HAD A CARDIAC ARREST AND ON ACCOUNT OF HYPOXIA, THE BRAIN WAS SERIOUSLY AFFECTED WHICH MADE REVIVAL PRACTICALLY IMPOSSIBLE AND THE PATIENT PASSED AWAY 2 DAYS LATER. AT THAT TIME, THE MANUAL DRAIN VOLUME WAS 4300 CUBIC CENTIMETERS (CC). THE PATIENT WAS LOCATED AT A HOSPITAL. THE CAUSE OF DEATH WAS MULTIPLE ORGAN DYSFUNCTION SYNDROME AND HYPOXIC BRAIN DAMAGE. INDIRECT CAUSE OF DEATH WAS HYPERTENSION AND DIABETES MELLITUS. THE PATIENT'S SON QUESTIONED THE FUNCTIONING OF HOMECHOICE (HC) MACHINE DURING APD AND CARDIAC ARREST. AFTER TRANSFERRED TO THE INTENSIVE CARE UNIT, ABOUT 4300 CCS WERE DRAINED FROM THE PERITONEAL CAVITY AT THE TIME OF MANUAL DRAINING ON THE DAY OF DEATH.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 15, 2009 THAT A JAGTOME RX SPHINCTEROTOME DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON DECEMBER 14, 2009 (PATIENT GENDER, AGE AND WEIGHT ARE UNKNOWN).ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE CAME OUT OF THE SCOPE, THE TIP WAS COMPLETELY BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX SPHINCTEROTOME DEVICE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOME CHOICE, INTERNATIONAL 220V | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |