MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number 52510-15

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is pending.

Event Description

The event involved a triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, heparin coated, lf that the customer reported when adequately measuring the medication not being infused to the patient a cup was placed under the line over a 3 minute period.When drawn up in a syringe it was measured that 1 ml of the medication was not being infused this process was done twice and it showed the same result.The distal port was aspirated with no blood return but with the sound of air coming out of the line.The line was clamped and marked appropriately for no use.The central venous pressure (cvp) and introducer lines were checked, and there was proper blood return.The patient was clinically stable, denies shortness or breath, and vital signs were stable.The customer reported the physician gave the okay to not restart the flolan infusion until the morning with a proper peripheral inserted central catheter (picc) line placement.There was patient involvement, however, no adverse event, no patient harm, and no delay in therapy.

Manufacturer Narrative

H10: received one used list# 52510-15, triox¿ svo2/cco pa catheter, 8f, 110cm,j-tip, heparin coated, lf.Lot# unknown.The flolan solution residuals are observed in as received one (1) used list# 52510-15, are observed a crack on the dttp (colorless) adapto, impossible to flush.The reported complaint of medication was not infused was confirmed on the returned set.During visual inspection, a crack was observed on the female luer of the dtpp lumen.Crazing was also observed around the crack.Blood residuals were also observed inside the dtpp lumen.This residual blood could lead to an occlusion.All the lumens of the returned set was primed and pressure leak tested and a leak was observed from the crack of the female luer of the dtpp lumen.The probable cause of the crack on the dtpp lumen had occurred due to environmental stress during use.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRIOX SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, HEPARIN COATED, LF
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 10637009
• MDR Text Key: 210207200
• Report Number: 1713468-2020-00003
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 52510-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOLAN, MFR UNK