MINICAP TRANSFER SET

Report

Report Number: 1416980-2014-18253
Event Type: Injury
Date Received: June 6, 2014
Date of Event: May 9, 2014
Report Date: May 12, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT NO: (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN COMPLAINTS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I25011, H13J04064, H13K04070 AND H13L02031 WAS PERFORMED 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 SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. 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 MANIFESTED AS CLOUDY EFFLUENT AND NOT FEELING WELL COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THREE DAYS AFTER THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH UNKNOWN ANTIBIOTICS FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORTED 3 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332473	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Hospitalization\| R	HOMECHOICE, CASSETTE, MINICAP\| DIANEAL PD4 1.5%, 2.5%, AND 4.25% AMBUFLEX