HOMECHOICE AUTOMATED PD SET WITH CASSETTE

Report

Report Number: 1416980-2013-02245
Event Type: Malfunction
Date Received: January 30, 2013
Date of Event: January 4, 2013
Report Date: January 5, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS LOOSE CONNECTION. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

A REGISTERED NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT OCCURRED ON THE HOMECHOICE (HC) DURING DWELL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SYSTEM ERROR 2240 TO THE RN. THE RN ALREADY KNEW THIS ALARM AND HAD ALREADY ASSISTED THE HOME PATIENT (HP) WITH CLEARING THIS ALARM ON THE HC. THE RN NEEDED TO CONFIRM WITH BAXTER TECH SUPPORT THE PROPER STEPS TO RESOLVE AND CLEAR THE ALARM. THE TSR EXPLAINED THE PROPER STEPS, WHICH THE RN HAD ALREADY FOLLOWED. THE RN SAID THAT THE HP HAD A LEAK OR DAMAGE TO ONE OF THE SUPPLIES, WHICH CAUSED THE SYSTEM ERROR 2240 TO COME ON THE HC. THE RN SAID THAT THE HP STARTED OVER WITH ALL NEW SUPPLIES ON THE HC. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THE PATIENT LINE DID NOT BECOME SEPARATED FROM THE TRANSFER SET. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES. THE HOME CHOICE SET WAS NOT BEING REUSED. THE PATIENT DID NOT HAVE ANY PETS THAT CAUSED DAMAGE TO THE SUPPLIES. THERE WAS NO DAMAGE NOTED TO THE OVERPOUCH OR THE CARTON IN WHICH THE CASSETTE WAS DELIVERED. A SHARP OBJECT WAS NOT USED TO ASSIST IN THE OPENING OF THE CARTON OR THE OVERPOUCH. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE ON (B)(4) 2013, IN REGARDS TO A SYSTEM ERROR 2240 ALARM AND SHE SAID SHE WAS NOT SURE WHERE THE LEAK WAS. SHE SAID SHE WAS ON THE PHONE WITH THE CAREGIVER WHO RELAYED TO HER THAT THERE WAS A LEAK SOMEWHERE. SHE GAVE THE PATIENT ANTIBIOTICS AS A PRECAUTIONARY MEASURE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S CAREGIVER ON 1/8/13 IN REGARDS TO A SYSTEM ERROR 2240 ALARM AND HE SAID THAT THERE WAS A LEAK SOMEWHERE BECAUSE UNDER ONE OF THE GREEN SUPPLY BAGS THERE WAS MOISTURE. HE SAID THERE WAS SOLUTION NEAR THE CONNECTION POINT OF THE BAG TO THE LINE AND HE BELIEVES THAT HE MAY NOT HAVE TIGHTENED THAT CONNECTION WELL ENOUGH SO THAT SOLUTION MAY HAVE LEAKED FROM THAT LOCATION. HE SAYS HE NOW INSPECTS THE BAGS AND CONNECTIONS MORE CAREFULLY BEFORE HELPING THE PATIENT BEGIN THERAPY. HE SAID THE PATIENT DID A MANUAL DRAIN AND THEN STARTED OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
41172	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR			HOME CHOICE