FDA Adverse Event Injury Summary report: N

UV-FLASH SOLUTION TRANS SET (48IN/122CM)- JAPAN

MDR report key: 1401262 · Received June 9, 2009

Report

Report Number
1423500-2009-00271
Event Type
Injury
Date Received
June 9, 2009
Date of Event
May 28, 2009
Report Date
May 28, 2009
Manufacturer
BAXTER HEALTHCARE -MOUNTAIN HOME
Product Code
KDJ
PMA / PMN Number
K883239
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN OF BACTERIAL PERITONITIS IN A MALE PT COINCIDENT WITH DIANEAL N PD-2 THERAPY. IN 2007, THE PT BEGAN DIANEAL N PD-2 1.5% 2500 (ML) TIMES 2 AND DIANEAL N PD-2 2.5% 2500ML TIMES 2 PER DAY. IN 2009, HIS UV TRANSFER SET WAS ROUTINELY EXCHANGED. FOUR MONTHS LATER, THE PT WAS HOSPITALIZED FOR PET (PERITONEAL EQUILIBRATION TEST). THE NEXT DAY, IN THE MORNING, A NURSE FOUND THAT THE PT'S PERITONEAL EFFLUENT WAS CLOUDY; HE HAD ABDOMINAL PAIN AND PYREXIA (37.5 DEGREE CELSIUS). SHE ALSO NOTICED THAT HIS PERITONEAL EFFLUENT VOLUME WAS LESS THAN EXPECTED. SHE CHECKED AND FOUND HIS UV TRANSFER SET HAD TWO CUTS IN THE TUBE AND WAS LEAKING. HIS UV TRANSFER SET WAS EXCHANGED FOR A NEW ONE. ON THE SAME DATE, HE WAS DIAGNOSED WITH PERITONITIS. HIS LEUCOCYTES COUNT IN HIS PERITONEAL EFFLUENT WAS HIGH (3980). HE WAS TREATED WITH CEFAMEZIN ALFA (1GRAM/DAY, INTRAPERITONEAL) AND MODACIN (1GRAM/DAY, INTRAPERITONEAL). ON THE SAME DATE, GRAM STAIN WAS PERFORMED AND THE RESULT REVEALED GRAM-NEGATIVE BACILLI. PERITONEAL EFFLUENT CULTURE WAS NOT PERFORMED. AS OF FOUR DAYS LATER, THE PT REMAINED HOSPITALIZED. THERE WERE NO ROUTINELY RE-USE SUPPLIES AND NO EXIT SITE/TUNNEL INFECTION. THE PT DID NOT HAVE A PERITONITIS EPISODE 4 WEEKS PRIOR TO CURRENT EPISODE. THE REPORTER THOUGHT THAT THE EVENT MIGHT HAVE BEEN RELATED TO THE PT'S BREAK IN ASEPTIC TECHNIQUE OR THE CUTS IN THE TRANSFER SET TUBING, THE PT WAS PLANNED TO BE RETRAINED. HIS PERITONEAL DIALYSIS THERAPY WAS ONGOING. THE PHYSICIAN ASSESSED THE EVENT AS NON-SERIOUS. SHE THOUGHT THAT THE EVENT WAS PROBABLY RELATED TO THE LEAK FROM UV TRANSFER SET AND NOT RELATED TO ANY OTHER BAXTER PRODUCTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UV-FLASH SOLUTION TRANS SET (48IN/122CM)- JAPAN 78KDJ KDJ BAXTER HEALTHCARE -MOUNTAIN HOME UNK

Patients

Seq Age Sex Outcome Treatment
1 69 YR Required Intervention