FDA Adverse Event Malfunction Summary report: N

AUTOMATED PD SET W/CASSETTE4 PRONG

MDR report key: 1943290 · Received December 31, 2010

Report

Report Number: 1423500-2010-07493
Event Type: Malfunction
Date Received: December 31, 2010
Date of Event: December 1, 2010
Report Date: December 2, 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). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NO ROOT-CAUSE HAS BEEN DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

Description of Event or Problem · 1

A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE UNIT DURING INITIAL DRAIN. DURING TROUBLESHOOTING WITH THE TECHNICAL SERVICE REPRESENTATIVE (TSR), THE HP STATED THERE WAS A BIG BUBBLE OF AIR IN THE PATIENT LINE. THE TSR ADVISED THE HP TO CYCLE POWER AND ASSISTED THE HP TO END THERAPY. THE TSR INSTRUCTED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL 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				PD CYCLER