FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2252943 · Received September 19, 2011

Report

Report Number: 1423500-2011-12370
Event Type: Malfunction
Date Received: September 19, 2011
Date of Event: September 2, 2011
Report Date: September 2, 2011
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

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.

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT IS CONFIRMED BECAUSE THE PATIENT STATED THAT HE WAS TRYING TO CAP OFF THE TRANSFER LINE FROM THE CASSETTE WHEN HE HIT IT AND THE PATIENT LINE FELL TO THE FLOOR. THE ASSIGNABLE CAUSE IS UNDETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING NEEDING ASSISTANCE TO END THERAPY AS HE BECAME DISCONNECTED FROM THE PATIENT LINE AND THE PATIENT LINE FELL TO THE FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) IN ENDING THERAPY. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE FOR FURTHER THERAPY INSTRUCTION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE