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

Model Number	BL+A430/V912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/03/2024
Type of Reportable Event	Death
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2024 due to low oxygen saturation and gi issues, discharged from the hospital on (b)(6) "2024".It was her first treatment in the clinic post hospitalization.Treatment started 7:07am with a blood pressure (bp) of 110/49 and it started dropping.7:30 - bp 93/43 mm/hg: 8:00 - bp 95/52 mm/hg and 9 am - bp was 99/38 mm/hg and they stopped the ultrafiltration (uf).Patient started vomiting and passed out, cpr was performed, fluids were given and paramedics were called.They tried ending the treatment but were unable to until after patient was pronounced dead @ 10:24 am.Dialyzer/bloodlines were saved.Staff stated that there were no alarms triggered before or during the event, except for treatment related alarms prior to event.Cause of death is still unknown.There were no issues reported with any of the nipro devices used.Treatment time - 3.5 hrs; blood flow rate (bfr) - 250; dialysate flow rate (dfr) - 600; a/b - 3k, 2.5; bicarb - 35, temp - 35.5; na - 138; access: cvc; uf goal - 4l; uf removed - 1.5 l; estimated dry weight (edw) - 74 kg; pre weight - 77.5 kg medications given; mircera - 60 mcg; venofer - 50 mg.Comorbids: cancer, chronic obstruction pulmonary disease (copd).Machine s/n: (b)(6).Machine pulled out of service, dialysate samples were drawn.Other devices use: nipro surdial dx hemodialysis system, code: mc+sdx01, serial (b)(6).Nipro elisio-h dialyzer, code: dd+elisio-17h, lot# 24c28h.
Additional Manufacturer Narrative
8/26/2024: correction made to section h5.Previously incorrectly selected "no".Corrected to "yes".
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2024 due to low oxygen saturation and gi issues, discharged from the hospital (b)(6) 2024.It was her first treatment in the clinic post hospitalization.Treatment started 7:07am with a blood pressure (bp) of 110/49 and it started dropping.7:30 - bp 93/43 mm/hg: 8:00 - bp 95/52 mm/hg and 9 am - bp was 99/38 mm/hg and they stopped the ultrafiltration (uf).Patient started vomiting and passed out, cpr was performed, fluids were given and paramedics were called.They tried ending the treatment but were unable to until after patient was pronounced dead @ 10:24 am.Dialyzer/bloodlines were saved.Staff stated that there were no alarms triggered before or during the event, except for treatment related alarms prior to event.Cause of death is still unknown.There were no issues reported with any of the nipro devices used.Treatment time - 3.5 hrs; blood flow rate (bfr) - 250; dialysate flow rate (dfr) - 600; a/b - 3k, 2.5; bicarb - 35, temp - 35.5; na - 138; access: cvc; uf goal - 4l; uf removed - 1.5 l; estimated dry weight (edw) - 74 kg; pre weight - 77.5 kg.Medications given; mircera - 60 mcg; venofer - 50 mg.Comorbids: cancer, chronic obstruction pulmonary disease (copd).Machine s/n: (b)(6).Machine pulled out of service; dialysate samples were drawn.Other devices use: nipro surdial dx hemodialysis system, code: mc+sdx01, serial# (b)(6).Nipro elisio-h dialyzer, code: dd+elisio-17h, lot# 24c28h.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• Common Device Name: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 19889657
• Report Number: 8041145-2024-00011
• Device Sequence Number: 7628691
• Product Code: KDI
• UDI-Device Identifier: 00383790008808
• UDI-Public: 00383790008808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BL+A430/V912
• Device Lot Number: 23K29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female