FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2243437 · Received September 12, 2011

Report

Report Number: 1423500-2011-12071
Event Type: Malfunction
Date Received: September 12, 2011
Date of Event: August 24, 2011
Report Date: August 24, 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 SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Additional Manufacturer Narrative · 1

(B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 4 OF 4. THE CALLER DID NOT SEE ANY OBVIOUS REASON FOR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AND ASSISTED TO CLEAR THE ALARM. THE HP WOULD DISCARD THE SUPPLIES AND CONTACT THE NURSE REGARDING THE AIR DETECT ALARM AND BEING CONNECTED AS WELL AS ANY MISSED THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

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

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE