HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3831313 · Received May 24, 2014

Report

Report Number: 1416980-2014-16956
Event Type: Malfunction
Date Received: May 24, 2014
Date of Event: January 30, 2014
Report Date: January 30, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN SET) ALARM OCCURRED DURING DWELL THREE OF FOUR ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE EVENT. THE HP STATED THE IT WAS WET UNDERNEATH A SUPPLY BAG. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP IN CLEARING THE ALARM. UPON FOLLOW UP, THE HP STATED THAT THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE BAG SUCH AS A CUT, SLICE, OR HOLE. THE HP WAS NOT SURE WHY IT WOULD BE WET UNDER THE BAG OTHER THAN POSSIBLY NOT TIGHTENING THE CONNECTION AS TIGHT AS NORMAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
309655	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	90 YR			HOMECHOICE