MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-42854-HP

Device Problem Improper Flow or Infusion (2954)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Iv antibiotics qn# (b)(4).

Event Description

Patient with labile blood pressure aiming to maintain map of 65mmhg with noradrenaline.Patient was on right side when albumin (b)(6) bolus was given and patient's systolic blood pressure increaesd to 200 and map 115.The (b)(6) were stopped and the patient's blood pressure stabilized.(b)(6) was restarted at 5ml/hr achieving map of 64.(b)(6) started again for 30 seconds then stopped as map increased to 94.The cvc was removed and replaced with a picc.No other medical intervention required.No patient harm was reported.The patient was reported to be fine.

Event Description

Patient with labile blood pressure aiming to maintain map of >65mmhg with noradrenaline.Patient was on right side when albumin 4% bolus was given and patient's systolic blood pressure increaesd to >200 and map >115.The noradrenaline and albumin were stopped and the patient's blood pressure stabilized.Noradrenaline was restarted at 5ml/hr achieving map of 64.Albumin started again for 30 seconds then stopped as map increased to 94.The cvc was removed and replaced with a picc.No other medical intervention required.No patient harm was reported.The patient was reported to be fine.

Manufacturer Narrative

Continuation of d11: iv antibiotics.(b)(4).The customer returned one 4-lumen catheter for investigation.Visual examination revealed no obvious defects or anomalies.The total length of the returned catheter body measured to be 169 mm which is within specifications of 157-177 mm per product drawing.Functional inspection was performed per the instructions-for-use (ifu) provided with this kit.The ifu states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all three lumens were flushed using a water-filled lab inventory syringe.No leaks or blockages were detected.When each lumen was flushed, water exited the respective skive location.No issues were detected.The distal tip of the catheter was then clamped.A lab inventory syringe was used to pressurize each lumen.No backflow was observed in any of the extension lines.A lab inventory guide wire (of the same size as the guide wire provided with this kit) was advanced through the distal lumen and exited through the distal tip.No issues were identified.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "using catheters not indicated for high pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." the customer report of inter lumen crossover could not be confirmed through functional testing of the returned sample.The catheter passed all relevant visual, dimensional, and functional testing, and a device history record review was performed on a potential lot (identified from a sales history review for this customer) and no relevant findings were identified.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13387492
• MDR Text Key: 285013067
• Report Number: 3006425876-2022-00107
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CS-42854-HP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/09/2022
• 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
• Treatment: NORADRENALINE 8MG/100MLS AT 4-9ML/HRINTERMITTENT; NORADRENALINE 8MG/100MLS AT 4-9ML/HRINTERMITTENT
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male