FDA Adverse Event Injury Summary report: N

FLEXICAP

MDR report key: 2771435 · Received October 4, 2012

Report

Report Number: 1416980-2012-01511
Event Type: Injury
Date Received: October 4, 2012
Date of Event: September 1, 2012
Report Date: September 13, 2012
Manufacturer: BAXTER HEALTHCARE - SWINFORD
Product Code: KDJ
PMA / PMN Number: K972579
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER 12A17H25. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE THE CAUSE OF THE PERITONITIS COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4). THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE IN (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). IT WAS NOT REPORTED WHETHER THE DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE PATIENT HAD NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Hospitalization	DIANEAL PD4 AMBUFLEX