MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F (; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken dialysis catheter arterial lumen was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs depicting a power trialysis acute dialysis catheter.Blood residue was abundant throughout the depicted device.A complete break was observed in the arterial lumen extension tubing.The break site appeared rough and irregular.The tubing appeared deformed in the vicinity of the break.Catheter damage was evident in the submitted photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include sharp instrument contact and material fatigue.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that "eeg tech at patient bedside removing eeg leads (did not have scissors).Patient with crrt running through right ij trialysis catheter with no problems identified.Crrt machine red alarmed.This rn immediately to bedside to address alarm.Alarm indicated arterial air.This rn noticed air filled arterial crrt line.Upon assesment, vas cath site was bleeding.Both lumens of vas cath clamped.Further assessment revealed arterial access line of vas cath transected/broke in half.Pressure held to right ij vas cath site.Md immediately to bedside to assist in holding pressure.Line emergently removed by md.Patient platelets are in 30s.Crrt filter blood loss (170ml) and saturation of 3 packs of 4x4 gauze/bed pad.Hemoglobin remained stable post incident, though patient on three pressors: levo at 30, epi at 9, and vaso.Epi was increased to 15 to maintain bp during incident.Photos taken of vas cath and given to clinical educator.Vas cath unable to be immediately replaced and patient will be going without needed crrt until line is replaced." it was stated that the patient "lost a considerable amount of blood causing more medication use".

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F (
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8960257
• Report Number: 3006260740-2019-02589
• Device Sequence Number: 2687974
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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 Model Number: N/A
• Device Catalogue Number: 5605150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention