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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET; BLOODLINES
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NIPRO THAILAND CORPORATION LTD NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET; BLOODLINES Back to Search Results
Model Number BL+A209Y/V803
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem Syncope (1610)
Event Date 10/02/2014
Event Type  Injury  
Event Description
Patient was initiated on dialysis treatment, after the first 10 minutes the patient did not respond and had a syncopal episode for about 30 seconds, the rapid response team was called for medical intervention, patient was then transferred to the intensive care unit.
 
Manufacturer Narrative
No investigation conducted due to lack of information from distributor, no lot number available, no device returned.Device not returned to manufacturer.
 
Manufacturer Narrative
Additional data in event problem codes and evaluation codes.Reserve samples evaluated by manufacturer.Device not returned to manufacturer.
 
Event Description
Patient was initiated on dialysis treatment, after the first 10 minutes the patient did not respond and had a syncopal episode for about 30 seconds, the rapid response team was called for medical intervention, patient was then transferred to the intensive care unit.
 
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Brand Name
NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
Type of Device
BLOODLINES
Manufacturer (Section D)
NIPRO THAILAND CORPORATION LTD
10/2 moo 8, bangnomko, sena
phra nakhon si
ayutthaya 13110, th
TH 
Manufacturer (Section G)
NIPRO THAILAND CORPORATION LTD
10/2 moo 8, bangnomko, sena
phra nakhon si
ayutthaya 13110, th
TH  
Manufacturer Contact
michelle tejada
3150 nw 107th avenue
miami, FL 33172
3055997174
MDR Report Key4896556
MDR Text Key6017903
Report Number8041145-2014-00005
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 11/17/2014,04/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberBL+A209Y/V803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2014
Distributor Facility Aware Date10/30/2014
Event Location Hospital
Date Report to Manufacturer11/17/2014
Date Manufacturer Received11/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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