MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920480
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Connection Problem (2900)
Health Effect - Clinical Code	Coma (2417)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that an 83-year-old male patient with chronic hemodialysis was initially hospitalized due to a suspected catheter in fection.After catheter replacement, a nurse observed the dialysis catheter open, unclamped, without a luer hub cap, and blood on the floor.The nurse clamped the line and left to grab some compresses.Upon returning, the patient was non-reactive and comatose (gcs 6).The patient spontaneously opened his eyes, being in and out of consciousness and occasionally responsive to simple questions.The patient was transferred to the icu due to a suspected air embolus caused by an iatrogenic injury to the right jugular vein.A cerebral ct scan did not detect any air bubbles at the encephalic level.The patient woke up on day 1 after sedation was stopped, and nad (nicotinamide adenine dinucleotide) levels were subsequently increased.The patient is currently hospitalized for pneumothorax associated with spherical bacteria.
Event or Problem Description
It was reported that an 83-year-old male patient with chronic hemodialysis was initially hospitalized due to a suspected catheter infection.After catheter replacement, a nurse observed the dialysis catheter open, unclamped, without a luer hub cap, and blood on the floor.The nurse clamped the line and left to grab some compresses.Upon returning, the patient was non-reactive and comatose (gcs 6).The patient spontaneously opened his eyes, being in and out of consciousness and occasionally responsive to simple questions.The patient was transferred to the icu due to a suspected air embolus caused by an iatrogenic injury to the right jugular vein.A cerebral ct scan did not detect any air bubbles at the encephalic level.The patient woke up on day 1 after sedation was stopped, and nad (nicotinamide adenine dinucleotide) levels were subsequently increased.The patient is currently hospitalized for pneumothorax associated with spherical bacteria.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20953028
• Report Number: 9680794-2024-01247
• Device Sequence Number: 20894148
• Product Code: MSD
• UDI-Device Identifier: 00801902096432
• UDI-Public: (01)00801902096432(11)210825(17)260630(10)33F23F0723(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: IPN920480
• Device Catalogue Number: CS-15322-VSP
• Device Lot Number: 33F23F0723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 85 KG