MINICAP TRANSFER SET

MDR report key: 3915755 · Received July 7, 2014

Report

Report Number: 1416980-2014-21655
Event Type: Malfunction
Date Received: July 7, 2014
Date of Event: May 3, 2014
Report Date: June 12, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). 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 WAS CONDUCTED 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. A SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE TUBING NOTED TO BE SEPARATED FROM THE DARK BLUE CONNECTOR. A LEAK TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SIDE OF THE TRANSFER SET WAS FOUND TO BE DAMAGED WHILE A PATIENT WAS PERFORMING PERITONEAL DIALYSIS THERAPY. THIS RESULTED IN A DISCONNECTION BETWEEN THE TRANSFER SET CONNECTOR AND TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
394011	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		H13J09048

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR