MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINE

Model Number BL+A223D/V809D

Device Problems Obstruction of Flow (2423); Device Operational Issue (2914)

Patient Problems Syncope (1610); Diaphoresis (2452)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Investigation report attached is on retained samples only, pending return of actual used device from customer.

Event Description

On (b)(6) 2018, baxter product surveillance received a call from an administrator regarding an arterial line that was filled with air (product code: (b)(4), lot #: 17k-20-6 or 17k-28-9).The administrator stated that there was no drug associated with the treatment.The administrator stated that the patient became hypotensive, diaphoretic and lost consciousness.They gave oxygen support since the patient had an agonal breathing and they bagged the patient and the patient regained consciousness.The patient was placed in a left side lying position and was sent to the hospital.They performed a cat scan and saw that there was no air in the system.They kept the patient in the hospital overnight for observation.The administrator stated that they don't know the exact lot number which had the air in the arterial line.The sample is available.There was patient involvement and patient injury was indicated at the time of initial report.

Event Description

On 10-apr-2018, baxter product surveillance received a call from an administrator regarding an arterial line that was filled with air (product code: a223dv809d, lot #: 17k-20-6 or 17k-28-9).The administrator stated that there was no drug associated with the treatment.The administrator stated that the patient became hypotensive, diaphoretic and lost consciousness.They gave oxygen support since the patient had an agonal breathing and they bagged the patient and the patient regained consciousness.The patient was placed in a left side lying position and was sent to the hospital.They performed a cat scan and saw that there was no air in the system.They kept the patient in the hospital overnight for observation.The administrator stated that they don't know the exact lot number which had the air in the arterial line.The sample is available.There was patient involvement and patient injury was indicated at the time of initial report.

Manufacturer Narrative

Investigation report attached is on retained samples only, pending return of actual used device from customer.8/30/18: device was never returned by the customer for factory evaluation.Final investigation attached on retained samples only.Revised section h6: revised & added event problem and evaluation codes: device code from 2914 to 2423.Method code removed codes from 38, 3317, 3330, 3340 to 11, 3331, 4114.Conclusion code from 92 to 4310 & 67.8/30/18: removed conclusion code 92.

Manufacturer Narrative

Investigation report attached is on retained samples only, pending return of actual used devce from customer.8/30/18: device was never returned by the customer for factory evaluation.Final investigation attached on retained samples only.Revised section e3, g4, and g7 revised section h6: revised & added event problem and evaluation codes: device code from 2914 to 2423 method code removed codes from 38, 3317, 3330, 3340 to 11, 3331, 4114 concluclusion code from 92 to 4310 & 67.

Event Description

On 10-apr-2018, baxter product surveillance received a call from an administrator regarding an arterial line that was filled with air (product code: a223dv809d., lot #: 17k-20-6 or 17k-28-9).The administrator stated that there was no drug associated with the treatment.The administrator stated that the patient became hypotensive, diaphoretic and lost consciousness.They gave oxygen support since the patient had an agonal breathing and they bagged the patient and the patient regained consciousness.The patient was placed in a left side lying position and was sent to the hospital.They performed a cat scan and saw that there was no air in the system.They kept the patient in the hospital overnight for observation.The administrator stated that they don't know the exact lot number which had the air in the arterial line.The sample is available.There was patient involvement and patient injury was indicated at the time of initial report.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 7499625
• MDR Text Key: 107776007
• Report Number: 8041145-2018-00016
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00383790004176
• UDI-Public: 00383790004176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018,08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL+A223D/V809D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2018
• Distributor Facility Aware Date: 04/16/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/09/2018
• Date Manufacturer Received: 04/16/2018
• 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 Number: 1
• Patient Outcome(s): Hospitalization