FDA Adverse Event Injury Summary report: N

CVC SET: 2-LUMEN 12 FR X 16 CM

MDR report key: 1884189 · Received June 11, 2010

Report

Report Number: 3006425876-2010-00026
Event Type: Injury
Date Received: June 11, 2010
Date of Event: June 12, 2009
Report Date: March 30, 2010
Manufacturer: ARROW INTERNATIONAL INC
Product Code: LFJ
PMA / PMN Number: K895417
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS ONE OF 5 RECORDS REFLECTING MULTIPLE OCCURRENCES (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR #3006425876-2009-00050, MDR #3006425876-2010-00025, MDR #3006425876-2010-00027, MDR #3006425876-2010-00028. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM JANUARY 1, 2009 THROUGH JULY 27, 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE F/U FOR THIS MDR.

Description of Event or Problem · 1

IT WAS REPORTED BY THE CLINICIAN THAT THERE IS A PROBLEM WITH A VARIANCE BETWEEN THE REAL PRIMING VOLUME (MEASURE WITH A SYRINGE) AND THE PRIMING VOLUME INDICATED ON THE EXTENSION LINE OF THE CATHETER. THE DIFFERENCE IS APPROX 30%. USERS ARE AWARE OF THE PROBLEM BECAUSE PT HAD HEPARIN IN BLOOD. AT FIRST, THEY BELIEVED IT WAS A NURSES MISTAKE AS THEY DO A LOCK OF THE CATHETER WITH HEPARIN. BUT AFTER INVESTIGATION, THEY REALIZED THAT IT IS AN ISSUE WITH THE PRIMING VOLUME OF THE CATHETER. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CVC SET: 2-LUMEN 12 FR X 16 CM	ACUTE HEMODIALYSIS CATHETER PRODUCTS	LFJ	ARROW INTERNATIONAL INC		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other