SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Report
- Report Number
- 1416980-2012-01427
- Event Type
- Injury
- Date Received
- October 3, 2012
- Date of Event
- September 1, 2012
- Report Date
- September 11, 2012
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- NURSE
Narratives
(B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. THIS REPORT OF PERITONITIS - NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
(B)(4). ADDITIONAL INFORMATION: ON (B)(6) 2012, GLOBAL PHARMACOVIGILANCE CONTACTED THE NURSE AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, REMEDIAL TREATMENT WITH VANCOMYCIN, GENTAMICIN AND MEROPENEM WAS STOPPED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENTS INITIALLY DESCRIBED (ABDOMINAL PAIN, CLOUDY EFFLUENT, BACTERIAL PERITONITIS AND CATHETER REMOVAL). ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PATIENT WAS STILL PERFORMING HEMODIALYSIS. THE NURSE STATED THE BACTERIAL PERITONITIS WAS NOT ASSOCIATED TO BAXTER PERITONEAL DIALYSIS (PD) SOLUTIONS OR BAXTER MEDICAL DEVICES.
THIS IS A SPONTANEOUS REPORT FROM GLOBAL PHARMACOVIGILANCE REPORTED BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS AERUGINOSA AND PERITONEAL ADHESIONS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2012, REMEDIAL TREATMENT WITH VANCOMYCIN (2GRAMS, IP) AND GENTAMICIN (80 MG, IP) WERE INITIATED FOR THE PERITONITIS. THE FREQUENCY OF ADMINISTRATION OF BOTH ANTIBIOTICS WAS DETERMINED BY THE MEASUREMENT OF DRUG LEVELS IN THE BLOOD. ON (B)(6) 2012, THE SYMPTOMS WORSENED AND PATIENT WAS HOSPITALIZED. ON (B)(6) 2012, THE PATIENT BEGAN REMEDIAL TREATMENT WITH MEROPENEM (500MG DAILY, INTRAVENOUSLY (IV)) FOR THE PERITONITIS WHICH WAS ONGOING. ON (B)(6) 2012, REMEDIAL TREATMENT WITH VANCOMYCIN WAS CHANGED TO 2 GRAMS IV (FREQUENCY NOT REPORTED) AND GENTAMICIN IP WAS STOPPED. ON AN UNREPORTED DATE, GENTAMICIN (40MG, IV), (FREQUENCY NOT REPORTED) WAS STARTED FOR THE PERITONITIS AND WAS ONGOING. ON (B)(6) 2012, THE PATIENT'S PD CATHETER WAS REMOVED AND PD THERAPY WAS TEMPORARILY WITHDRAWN. A FEW PERITONEAL ADHESIONS WERE FOUND DURING THE CATHETER REMOVAL SURGERY. ON (B)(6) 2012 PATIENT STARTED HEMODIALYSIS. AS OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. THE PATIENT WAS RECOVERING FROM PERITONITIS. OUTCOME OF PERITONEAL ADHESIONS WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| R | EXTRANEAL| UNUSUAL THERAPIES FOR ESRD AND HYPERTENSION| HOMECHOICE| PHYSIONEAL 40 2.27%| PHYSIONEAL 40 1.36% |