FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2081830 · Received May 9, 2011

Report

Report Number: 1423500-2011-05628
Event Type: Malfunction
Date Received: May 9, 2011
Date of Event: April 14, 2011
Report Date: April 14, 2011
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). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

Description of Event or Problem · 1

THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CLEAR THE ALARM AND EXPLAINED THE SE 2240 INDICATED AIR ENTERED THE SET UP. THE HP STATED HE WOULD COMPLETE THERAPY WITH A MANUAL EXCHANGE. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE CAREGIVER (CG) WHO STATED NOTHING UNUSUAL WAS NOTED WITH THE SUPPLIES AND THERAPY HAS RESUMED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME		H10C21024

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR			HOMECHOICE PRO