SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Report
- Report Number
- 1416980-2013-03986
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- January 23, 2013
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
(B)(4). THE EXACT DATE OF THE EVENT IS UNKNOWN, HOWEVER THE EVENT WAS REPORTED TO HAVE OCCURRED IN 2011. EVALUATION SUMMARY: AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE PROBLEM WAS NOT CONFIRMED, AS A SAMPLE COULD NOT BE EVALUATED. THEREFORE THE CAUSE OF THE PERITONITIS COULD NOT BE DETERMINED, AS NO DEVICE MALFUNCTION NOR USE ERROR WAS IDENTIFIED DURING THE REPORT. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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.
BAXTER (B)(4) RECEIVED A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). THE PATIENT EXPERIENCED STOMACH PROBLEMS AND PERITONITIS. THE PATIENT WENT TO THE HOSPITAL FOR MILD TREATMENT AND WAS TREATED WITH UNSPECIFIED MEDICATIONS. THE PATIENT WAS NOT SURE ABOUT WHAT CAUSED THE CONTAMINATION AND REPORTED THAT HE MIGHT HAD TOUCHED SOMETHING. THIS EVENT OF PERITONITIS WAS NOT BACTERIAL AND THE PATIENT HAS RECOVERED FROM THIS PERITONITIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67804 | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | DIANEAL PD4 2.5%| DIANEAL PD4 4.25%| EXTRANEAL| DIANEAL PD4 1.5% |