FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1880416 · Received October 22, 2010

Report

Report Number: 1423500-2010-04825
Event Type: Malfunction
Date Received: October 22, 2010
Date of Event: October 5, 2010
Report Date: October 5, 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 ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A HOME PATIENT (HP) CONTACTED (B)(6) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FINAL DWELL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAD ENTERED CASSETTE. THE HP WAS IN HER FINAL DWELL SO SHE WAS GOING TO DISCONTINUE THERAPY FOR THE NIGHT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOMATED PD SET W/CASSETTE4 PRONG	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	4 MO