PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

MDR report key: 1910694 · Received November 30, 2010

Report

Report Number: 1423500-2010-06368
Event Type: Injury
Date Received: November 30, 2010
Date of Event: October 10, 2010
Report Date: October 10, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K053512
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT REQUESTED FOR EVALUTION AS IT WAS FUNCTIONING PROPERLY WHEN THE ORIGINAL CALL CAME IN.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF THE ORIGINAL DEVICE HISTORY RECORD, (B)(6) 2006, SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE (B)(6) FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF LOW DRAIN VOLUME ALARMS, POSSIBLY CAUSED BY PATIENT HERNIA. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

Description of Event or Problem · 1

THE CARE GIVER (CG) CALLED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) AND STATED THAT THE HOME PATIENT (HP) HAS A HERNIA AND SHE WAS NOT SURE IF THE HERNIA COULD BE CAUSING THE LOW DRAIN VOLUME ALARMS THAT THEY HAVE BEEN EXPERIENCING. THE CG STATED THAT THE HP WAS GOING TO HAVE ANOTHER OPERATION FOR THE HERNIA. THE LOW DRAIN VOLUME ALARMS WERE CLEARED BY REPOSITIONING THE HP. THE TSR RECOMMENDED THAT THE CG CONTACT THE NURSE REGARDING THE ALARMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R