FDA Adverse Event Malfunction Summary report: N

UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

MDR report key: 1760910 · Received July 19, 2010

Report

Report Number: 1423500-2010-01538
Event Type: Malfunction
Date Received: July 19, 2010
Date of Event: June 23, 2010
Report Date: June 29, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB. THE RESULTS OF A SAMPLE EVALUATION REVEALED THAT THE TIP OF THE SPIKE WAS BENT INWARD. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE WAS UNDETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

Description of Event or Problem · 1

AN ALARM OCCURRED WHEN THE TRANSFER SET WAS TRYING TO BE CONNECTED TO THE YUME SET. THE PATIENT CONNECTED THE TRANSFER SET AND YUME SET FOLLOWING ADVICE FROM THE BAXTER CALL CENTER, BUT A BENT SPIKE WAS FOUND WHEN THE TRANSFER SET WAS PICKED UP FROM THE CLEANFLASH AFTER CONNECTING TO THE YUME SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1