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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CV-12853
Device Problem Complete Blockage (1094)
Patient Problem Death (1802)
Event Date 12/18/2018
Event Type  Death  
Manufacturer Narrative

(b)(4). At this time the customer cannot confirm if the alleged issue with the device caused or contributed to the outcome of the patient's death.

 
Event Description

It was reported that: whilst the dialyze was plugged in, using the push syringes plugged on the proximal lines, the alarm of these push syringes rang. The message was indicating a blockage of this line with consequences for the patient to have its tension pressure falling. Clinical consequences: the patient could not get its treatment (catecholamines). So, another central venous line was inserted in urgency to find a temporary solution connecting the catecholamines on the distal line to have the tension getting up.

 
Manufacturer Narrative

(b)(4). The customer returned one three-lumen cvc for evaluation. Visual inspection was performed, and biological material was observed inside the catheter body near the distal tip. No other defects or anomalies were observed. A dimensional inspection was also performed and the sample met all relevant dimensional requirements. A lab inventory ars syringe was used to pass water through all three extension lines. The water was able to pass with little difficulty. No blockages were observed. A leak test was performed on all three extension lines. With the body of the catheter occluded, a lab inventory syringe was used to inject water through each lumen. No leaks were observed. A straight wire with a diameter of. 032" was inserted through the distal and proximal end of the three extension lines. No significant resistance or blockages were observed for any of the lumens. A device history record review was performed with no relevant findings to suggest a manufacturing issue. The ifu provided with the kit, warns the user that after inserting the catheter, "flush lumen(s) to completely clear blood from catheter. " the ifu also cautions, "do not leave open needles or uncapped, unclamped catheters in central venous puncture site. Air embolus can occur with these practices. " the customer reported issue of a blockage in one of the extension lines was not confirmed during the sample investigation. Visual and functional inspections were performed, and no issues were identified. The sample met all relevant dimensional requirements, and a device history record review was performed with no relevant findings. No problem was found with the returned sample. Teleflex will continue to monitor and trend for reports of this nature.

 
Event Description

It was reported that: whilst the dialyze was plugged in, using the push syringes plugged on the proximal lines, the alarm of these push syringes rang. The message was indicating a blockage of this line with consequences for the patient to have its tension pressure falling. Clinical consequences: the patient could not get its treatment (catecholamines). So, another central venous line was inserted in urgency to find a temporary solution connecting the catecholamines on the distal line to have the tension getting up.

 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 16CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8261753
MDR Text Key133560268
Report Number3006425876-2019-00001
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCV-12853
Device LOT Number71F18G1969
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/31/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/18/2019 Patient Sequence Number: 1
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