DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

MDR report key: 4090138 · Received September 15, 2014

Report

Report Number: 1416980-2014-31305
Event Type: Malfunction
Date Received: September 15, 2014
Date of Event: August 20, 2014
Report Date: August 21, 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). (B)(6). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). PHOTOGRAPH OF ACTUAL SAMPLE WAS PROVIDED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED AND NOTED NO ISSUES DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION NOTED. A RETAINED SAMPLE OF THIS LOT WAS EVALUATED, BUT NOTHING WAS FOUND RELATED TO THE REPORTED CONDITION. A PHOTOGRAPHIC SAMPLE WAS PROVIDED AND EVALUATED. THE VISUAL INSPECTION OF THE PHOTOGRAPH IDENTIFIED PHYSICAL DAMAGE, SPECIFICALLY ON THE HANDHOLD OF THE BOTTLE, WHICH WAS A LIKELY CAUSE OF THE REPORTED LEAK. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A LEAK DUE TO DAMAGE IN THE PRIMARY CONTAINER OF AN ACID CONCENTRATE. THE DAMAGE IS LOCATED ON THE HANDHOLD OF THE BOTTLE. THIS WAS FOUND DURING THE TIME THE PRODUCT WAS RECEIVED, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 17.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
569812		DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)	KPO	BAXTER HEALTHCARE - SANTIAGO		14A0042

Patients

Seq	Age	Sex	Outcome	Treatment
1