MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 11CM CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-20854

Device Problem Gas Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the patient was receiving large doses of inotropes. The patient's bp noted to be dangerously low and not increasing with addition of the double strength infusion. It was noted air intermittently present in the clear tubing section of the white cvc proximal port. All infusion lines and connections checked for correct fit and damage, nothing noted. Both inotrope infusions moved to the brown distal cvc port and air continued to be intermittently drawn into clear line of the brown port. All new inotrope infusions made and connected with new lines and new 3-way taps connected back to the white port. Issue resolved. No patient injury reported.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 11CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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 ; 9194334854
• MDR Report Key: 8808195
• MDR Text Key: 151616759
• Report Number: 3006425876-2019-00507
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CV-20854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2019
• 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