MINICAP TRANSFER SET

Report

Report Number: 1416980-2013-03995
Event Type: Injury
Date Received: February 15, 2013
Date of Event: January 7, 2013
Report Date: January 23, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: NURSE

Narratives

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.

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12E21068. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

Description of Event or Problem · 1

SAME PATIENT AS (B)(4). THIS IS A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). THE PATIENT HAD EXPERIENCED A MRSA INFECTION TWICE WITHIN A MONTH. A TREATMENT OF VANCOMYCIN IV (DOSAGE UNKNOWN) FOR THE MRSA INFECTION. DURING THIS TIME THE PATIENT WAS HOSPITALIZED FOR FUNGAL PERITONITIS, HOWEVER, TREATMENT FOR THE FUNGAL PERITONITIS WAS NOT REPORTED. ABOUT A WEEK LATER, THEY WERE REMOVED FROM PERITONEAL DIALYSIS AND MOVED ONTO HEMODIALYSIS. FOUR DAYS LATER THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS REPORTED TO HAVE BEEN RECOVERING. THE PATIENT WAS RETRAINED ON PROPER PD TECHNIQUE (DATE UNKNOWN).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
66949	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Hospitalization	DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG\| HOMECHOICE