FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 2821896 · Received November 7, 2012

Report

Report Number: 1416980-2012-04244
Event Type: Malfunction
Date Received: November 7, 2012
Date of Event: September 23, 2012
Report Date: October 15, 2012
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Removal / Correction Number: 1423500-01/08/10-001-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: SERVICE AND TESTING PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS CONDITION IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF ANOTHER CONDITION. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS A USE ERROR, AS THE TIDAL TOTAL UF REMOVAL SET TOO LOW. ADDITIONAL INFORMATION: THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012. DURING NIGHT DRAIN CYCLE TEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1129ML. THIS INDICATES THAT THE HOME PATIENT (HP) DRAINED 769ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1200ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1