FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1880117 · Received October 22, 2010

Report

Report Number: 1423500-2010-04775
Event Type: Malfunction
Date Received: October 22, 2010
Date of Event: September 30, 2010
Report Date: September 30, 2010
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (SE) 2240 ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

Description of Event or Problem · 1

A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 THAT APPEARED WHILE USING THE HOMECHOICE (HC) DURING DWELL 4 OF 4. THE PATIENT WAS CONNECTED DURING THE ERROR, HAS ALREADY CLEARED THE ERROR, AND DISCARDED THE SUPPLIES. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE, AND ADVISED THE PATIENT TO CONTACT THEIR DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR