CLEARLINK LUER ACTIVATED VALVE

MDR report key: 9836707 · Received March 16, 2020

Report

Report Number: 1416980-2020-01427
Event Type: Malfunction
Date Received: March 16, 2020
Date of Event: February 19, 2020
Report Date: April 13, 2020
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: FPA
PMA / PMN Number: K180739
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: (REMOVE DUO-VENT CLEARLINK LUER ACTIVATED VALVE REPORTED ON INITIAL). CATALOGUE # CLARIFICATION 2R8401. (REMOVE K112893 REPORTED ON INITIAL). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING; INCLUDING PRESSURE AND CLEAR PASSAGE UNDERWATER TESTING, WERE PERFORMED AND THE DEVICE OPERATED ACCORDING PRODUCT SPECIFICATIONS. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED A CLEARLINK SYSTEM SOLUTION SET BACK FLOWED. THE EVENT OCCURRED DURING A ONE-HOUR TAXOL INFUSION VIA GRAVITY. IT WAS OBSERVED ¿THE SECONDARY BAG BACKED UP INTO THE TAXOL TUBING. THE PRIMARY Y EXTENSION SITE WAS CLAMPED TO AVOID THE BACKFILL INTO THE TAXOL BAG. THE REST OF THE TAXOL WOULD NOT INFUSE VIA GRAVITY¿. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298035	CLEARLINK LUER ACTIVATED VALVE	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE CORPORATION	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1				EQUASHIELD\| TAXOL\| UNSPECIFIED ONE-LINK