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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC SET: 3-L 7 FR X 6" (16 CM) AGB+ CATHETER,INTRAVASCULAR,THERAPE

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ARROW INTERNATIONAL INC. ARROW PI CVC SET: 3-L 7 FR X 6" (16 CM) AGB+ CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number ASK-42703-PMC-S1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Coma (2417); Loss of consciousness (2418)
Event Date 10/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Several attempts made to user facility to obtain additional information regarding the reported event. No response from user facility at the time of this report.
 
Event Description
According to the medwatch ((b)(4)) "called to bedside as patient deteriorated rapidly during internal jugular central line removal. Patient became stuporous and with agonal breathing, severe hypoxemia ensued and supported him with ambu bag and 100% oxygen immediately. Eyes were noted to be fixed and deviated to upper left and unresponsive to stimuli. Patient then started to breathe spontaneously with normal respiratory effort but remained comatose. Bedside echocardiography revealed significant amount of air bubbles in the right heart. Patient remained comatose through this procedure but started to slowly respond to voice commands, corneal reflexes present and attempts to make spontaneous movements followed".
 
Event Description
According to the medwatch (2400100000-2018-8026) "called to bedside as patient deteriorated rapidly during internal jugular central line removal. Patient became stuporous and with agonal breathing, severe hypoxemia ensued and supported him with ambu bag and 100% oxygen immediately. Eyes were noted to be fixed and deviated to upper left and unresponsive to stimuli. Patient then started to breathe spontaneously with normal respiratory effort but remained comatose. Bedside echocardiography revealed significant amount of air bubbles in the right heart. Patient remained comatose through this procedure but started to slowly respond to voice commands, corneal reflexes present and attempts to make spontaneous movements followed".
 
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Brand NameARROW PI CVC SET: 3-L 7 FR X 6" (16 CM) AGB+
Type of DeviceCATHETER,INTRAVASCULAR,THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8137830
MDR Text Key129479478
Report Number3003737899-2018-00171
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberASK-42703-PMC-S1
Device Lot Number13F18G0533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2018
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: 12/06/2018 Patient Sequence Number: 1
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