inforMED
MalfunctionFKY

INTEGRATED APO SET W/CASSETTE3-PRONG

Received Dec 3, 2008 · Event occurred Nov 6, 2008

Report 1423500-2008-00963 · MDR key 1297835

Device

Generic name

78fky

Catalog number

5C4531C

Lot number

UNK

Product problems

  • Disconnection
  • Device Displays Incorrect Message

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SVC CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) UNIT DURING DRAIN 2 OF 4. THE HOME PT (HP) BECAME DISCONNECTED DURING THERAPY. THE HP DID NOT RECONNECT. THE TECHNICAL SVC REP (TSR) HAD THE HP CAP OFF THE PT LINE. THE HP CYCLED THE POWER TO CLEAR THE ERROR 2240. THE HP WILL CONTACT THE PERITONEAL DIALYSIS NURSE TO ADVISE OF THE PT LINE BECOMING DISCONNECTED. THE HC WAS OPERATIONAL. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

PER THE HOME PT, THE SAMPLE WAS DISCARDED.