MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS ST STRAIGHT DIALYSIS CATH FPT 13F 20CM TL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reez0983 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "patient was stable on crrt which was connected to a trialysis triple lumen dialysis catheter placed in his right internal jugular vein.The prismaflex machine alarmed and the rn found the return line disconnected from the patient and the alarm indicating air detected.The line from the triple lumen and crrt machine were immediately clamped.Crrt machine was stopped.The rn then aspirated air from the patient's triple lumen.Patient did not suffer any harm from the disconnection.Per family in the room when the alarm sounded, the patient was still in bed and had not been moving his head or upper body prior to the disconnection.The line was leaking at the junction between the crrt tubing and the patient's triple lumen central line.Baxter biomedical engineer evaluated the crrt machine and found no malfunctions.Data from the machine was downloaded by a baxter educator and a summary report from them is pending at this writing.Baxter is actively involved in the investigation for pnsmaflex set.".

• Brand Name: POWER-TRIALYSIS ST STRAIGHT DIALYSIS CATH FPT 13F 20CM TL
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12049789
• Report Number: 3006260740-2021-02405
• Device Sequence Number: 19731183
• Product Code: NIE
• UDI-Device Identifier: 00801741086960
• UDI-Public: (01)00801741086960
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5605200
• Device Lot Number: REEZ0983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/23/2021
• 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: Other
• Patient Age: 48 YR
• Patient Weight: 129