MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF BIOHOLE (DULL) NEEDLE WITH CAPICK; DULL AVF NEEDLE

Model Number AVD1520-HTC-30R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Neck Pain (2433)

Event Date 08/30/2021

Event Type  Death  

Manufacturer Narrative

Actual sample discarded, customer will return unused retained samples for investigation.

Event Description

45 minutes after the start of dialysis, the patient describes having severe pain at the base of the neck, then quickly triggers swelling of the tongue and face.First manoeuvers were started.Patient place in a lateral decubitis position, dialysis treatment was stopped, oxygen was administered, and uas call for management.Patient passed away.With the clinical signs presented, they were unable to determine the cause of death.Death seemed to be the result of anaphylactic shock without dialysis circuit dm.Other disposables used: hemotech bloodline, lot lk76613r.Fresenius dialyzer xcordiax 80, lot c2xa18160.Bellco acid concentrates.

Manufacturer Narrative

Actual sample discarded, customer will return unused retained samples for investigation.10/08/2021: investigation attached is on retained samples by the manufacturer only.Customer did not return any samples.

Event Description

45 minutes after the start of dialysis, the patient describes having severe pain at the base of the neck, then quickly triggers swelling of the tongue and face.First manoeuvers were started.Patient place in a lateral decubitis position, dialysis treatment was stopped, oxygen was administered, and uas call for management.Patient passed away.With the clinical signs presented, they were unable to determine the cause of death.Death seemed to be the result of anaphylactic shock without dialysis circuit dm.Other disposables used: hemotech bloodline, lot lk76613r.Fresenius dialyzer xcordiax 80, lot c2xa18160.Bellco acid concentrates.

• Brand Name: NIPRO AVF BIOHOLE (DULL) NEEDLE WITH CAPICK
• Type of Device: DULL AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• MDR Report Key: 12576469
• MDR Text Key: 274758599
• Report Number: 8041145-2021-00016
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• PMA/PMN Number: K100520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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
• Device Operator: Health Professional
• Device Model Number: AVD1520-HTC-30R
• Device Lot Number: 21E22G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death