SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2013-12940
Event Type: Injury
Date Received: May 20, 2013
Date of Event: April 9, 2013
Report Date: April 25, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. PER THE HOME PATIENT'S DAUGHTER, THE HOME PATIENT (HP) EXPERIENCED AN EPISODE OF DEMENTIA ONE EVENING (DATE UNKNOWN) AND DISCONNECTED HIMSELF DURING TREATMENT WITHOUT USING PROPER ASEPTIC TECHNIQUE. THE HP WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE HP WAS DIAGNOSED WITH PERITONITIS THE SAME DAY AS THE ADMISSION TO THE HOSPITAL. THE HP WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS (TYPE, DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED), FOR 4 DAYS WHILE IN THE HOSPITAL AND DISCHARGED WITH INTRAPERITONEALLY (IP) ANTIBIOTICS (TYPE, DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) FOR TWO ADDITIONAL WEEKS. NO ADDITIONAL INFORMATION IS AVAILABLE. OUTCOME: RECOVERED. MEDICAL HISTORY: END STAGE RENAL DISEASE (ESRD), DEMENTIA. CONCOMITANT THERAPY: NOT REPORTED. CAUSALITY ASSESSMENT: NOT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
221424		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization\| R	DIANEAL