FDA Adverse Event Malfunction Summary report: N

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

MDR report key: 3833913 · Received May 27, 2014

Report

Report Number: 1416980-2014-17124
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: April 28, 2014
Report Date: May 2, 2014
Manufacturer: BAXTER HEALTHCARE - SANTIAGO
Product Code: KPO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EC
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED PARTICULATE MATTER ON THE INTERNAL AND EXTERNAL SIDES OF THE BOTTLE. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR MICROBIOLOGICAL TESTING, WHICH FOUND THE PARTICULATE MATTER TO BE FUNGUS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE WAS UNABLE TO BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PLASTIC BOTTLE FILLED WITH 10L BASIC HEMOCONCENTRATE WAS CONTAMINATED WITH MOLD. THE BOTTLE WAS FOUND TO BE DAMAGED AND CONTAINED BLACK SPOTS THAT RESEMBLED MOLD. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310937		DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)	KPO	BAXTER HEALTHCARE - SANTIAGO		13E0359

Patients

Seq	Age	Sex	Outcome	Treatment
1