MINICAP TRANSFER SET

Report

Report Number: 1416980-2013-07426
Event Type: Injury
Date Received: March 27, 2013
Date of Event: February 23, 2013
Report Date: March 4, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12L07031. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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)

Description of Event or Problem · 1

THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY AUTOMATED PERITONEAL DIALYSIS (APD). DIANEAL THERAPY WAS ONGOING. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED AS ABDOMINAL PAIN AND WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE AND FREQUENCY UNKNOWN) IP FOR PERITONITIS. THE PATIENT WAS RE-TRAINED ON A PROPER ASEPTIC TECHNIQUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 5 OF 5.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
126748	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Hospitalization\| R	HOMECHOICE AND DIANEAL PD4 AMBUFLEX