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

Model Number BL+A209Y/V803

Device Problems Break (1069); Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Initial investigation report on retained representative samples, pending final investigation.

Event Description

During treatment the bloodline ruptured at the middle of the pump segment.Air entered the system and there was a blood loss of >100ml.No further information was provided.On (b)(6) 2017: our clinical specialist contact the clinic and according to the clinical manager, there were no injuries, medical interventions or hospitalization.Hemoglobin levels will be checked (b)(6) 2017.

Manufacturer Narrative

Initial investigation report on retained representative samples, pending final investigation on 3/7/2017: final investigation report on used returned samples(2), lot number not identified.

Event Description

During treatment the bloodline ruptured at the middle of the pump segment.Air entered the system and there was a blood loss of >100ml.No further information was provided on 1/5/2017: our clinical specialist contact the clinica and according to the clinical manager, there were no injuries, medical interventions or hospitalization.Hemoglobin levels will be checked (b)(6) 2017.

Manufacturer Narrative

Initial investigation report on retained representative samples, pending final investigation on 3/7/2017: final investigation report on used returned samples(2), lot number not identified.On 6/1/2017: revised final investigation report attached with pictures of the proper set up of the blood pump segment.

Event Description

During treatment the bloodline ruptured at the middle of the pump segment.Air entered the system and there was a blood loss of >100ml.No further information was provided on 1/5/2017: our clinical specialist contact the clinica and according to the clinical manager, there were no injuries, medical interventions or hospitalization.Hemoglobin levels will be checked 01/12/2017.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINES
• 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 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 6294783
• MDR Text Key: 66319010
• Report Number: 8041145-2017-00001
• Device Sequence Number: 1
• Product Code: FJK
• 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: distributor,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2017,06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL+A209Y/V803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2017
• Distributor Facility Aware Date: 01/05/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/01/2017
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other