FDA Adverse Event Malfunction Summary report: N

INTEGRATED APD SET W/CASSETTE3-PRONG

MDR report key: 1914901 · Received December 6, 2010

Report

Report Number: 1423500-2010-06565
Event Type: Malfunction
Date Received: December 6, 2010
Date of Event: November 11, 2010
Report Date: November 11, 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). THIS REPORT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 3/4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE REPORT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE 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 AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) (B)(4), THIS SITUATION OCCURRED DURING DWELL 3 OF 4. THE HOME PATIENT (HP) WAS STILL CONNECTED AND THE SUPPLY BAG WAS EMPTY. THERE WAS SOLUTION IN THE HEATER BAG ONLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF ANY BAGS CAME UNDONE, PER THE HP, NO. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM BY TURNING THE HC OFF/ON, THEN SYSTEM ERROR 2367. THE HP TURNED THE HC OFF/ON AND THE HC WAS BACK TO PRESS GO TO START. THE HP FINISHED WITH A MANUAL BAG. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTEGRATED APD SET W/CASSETTE3-PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1