SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-22415
Event Type: Death
Date Received: July 11, 2014
Date of Event: June 17, 2014
Report Date: June 18, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT 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 PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND UNRELATED EVENTS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSAGE, ROUTE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE SAME MONTH, THE PATIENT HAD THE PD CATHETER REMOVED, STOPPED THE PD THERAPY AND WAS PLACED ON CONTINUOUS VENO VENOUS HEMOFILTRATION (CVVH). THE PATIENT DIED THE FOLLOWING MONTH WHILE HOSPITALIZED. IT WAS REPORTED THAT AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
406261		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Death\| H\| R	DIANEAL 1.5% AND 2.5% PD2 AMBUFLEX, EXTRANEAL