MINICAP TRANSFER SET

MDR report key: 3790842 · Received May 5, 2014

Report

Report Number: 1416980-2014-14502
Event Type: Malfunction
Date Received: May 5, 2014
Date of Event: April 9, 2014
Report Date: April 10, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K882498
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). IN ADDITION TO A VISUAL INSPECTION, WITH THE NAKED EYE, A MICROSCOPIC INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A LEAK TEST WAS PERFORMED WITH UNDERWATER PRESSURE TESTING. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS UNABLE TO BE DUPLICATED THROUGH A SAMPLE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A LEAK COMING FROM A TWIST CLAMP OF A MINICAP TRANSFER SET WITH TWIST CLAMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
266340	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1