FDA Adverse Event Injury Summary report: N

MINICAP TRANSFER SET

MDR report key: 2981391 · Received February 27, 2013

Report

Report Number: 1416980-2013-04828
Event Type: Injury
Date Received: February 27, 2013
Report Date: February 5, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AK, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12J11037, H12G27079, H12K09112 AND H12H31095 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

Additional Manufacturer Narrative · 1

(B)(4). APPROXIMATE DATE - (B)(6) 2012. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD ON GOING PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS. THE PATIENT HAS NOT YET RECOVERED FROM THIS EVENT. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
83975	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	DIANEAL PD4 AMBUFLEX