FDA Adverse Event Injury Summary report: N

HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

MDR report key: 523647 · Received May 3, 2004

Report

Report Number
1423500-2004-00415
Event Type
Injury
Date Received
May 3, 2004
Date of Event
March 1, 2004
Report Date
April 1, 2004
Manufacturer
BAXTER HEALTHCARE CORP.
Product Code
FKX
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NM, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A HOME PT'S (HP) NURSE REPORTED AN HP EXPERIENCED SHOULDER AND ABDOMINAL PAIN REPORTEDLY AFTER BEING INFUSED WITH AIR DURING THEIR APD THERAPY. PER THE HP, HP BEGAN FEELING SHOULDER AND ABDOMINAL PAIN DURING THE MIDDLE OF THEIR APD THERAPY. THEIR PRIME WAS PERFORMED WITH THE PT LINE CLAMP OPEN, THE UNUSED SUPPLY LINES CLOSED, AND NO PT EXTENSION LINES. PER THE HP, NOTHING UNUSUAL WAS NOTED WITH ANY OF THE SUPPLIES OR WITH THE THERAPY IN GENERAL. THE HP DOES NOT CHECK TO THE PT LINE OF THE HOMECHOICE SET TO CONFIRM THE SUCCESSFUL COMPLETION OF PRIME PRIOR TO CONNECTING TO THEIR TRANSFER SET. ADDITIONALLY, PER THE HP'S NURSE, THE HP DOES NOT HAVE AN INITIAL DRAIN AS HP BEGINS THEIR TREATMENT WITH AN EMPTY PERITONEUM. THE HP ADVISED THAT AFTER THE ONSET OF THE ABDOMINAL AND SHOULDER PAIN HP CONTINUED WITH THEIR THERAPY TO COMPLETION. APPROXIMATELY 2 DAYS LATER THE HP WENT TO THE EMERGENCY ROOM AS THEIR PAIN HAD NOT SUBSIDED. THE HP HAD AN X-RAY AND IT WAS CONFIRMED THAT THERE WAS AIR IN THEIR ABDOMEN. NEITHER MEDICATION NOR HOSPITALIZATION WAS REQUIRED. THE PT RETURNED HOME, AND THE SHOULDER PAIN AND ABDOMINAL PAIN EVENTUALLY SUBSIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

Patients

Seq Age Sex Outcome Treatment
1 53 YR Other MINICAP PD TRANSFER SET WITH TWIST CLAMP-EXTRA| HOMECHOICE PRO AUTOMATED PD SYSTEM 115 VOLT, 2004,| (STRENGTH UNKNOWN), 2004.| SHORT, 2004, DIANEAL LOW CALCIUM SOLUTION