MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SLIM-CATH PRECURVED EXTENSION SHORT-TERM DIALYSIS CATHETER FULL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Catalog Number	5865150
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rezh1074 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
As reported via ms&s: sales representative had nurse conference call with ms&s.The nurse stated that they had a female patient with known sepsis who had a power trialysis placed on (b)(6) 2016.The nurse stated that the patient's chest and neck veins were exhausted and the right groin had an infection.The power trialysis was placed into the left femoral vein but was only 15cm in length.The nurse stated that the venous purple lumen was being used for vasopressors levophed and dopamine during ccrt.The nurse reported that the patient's blood pressure was low and then would elevate.Nurse stated that the patient deteriorated.The family stopped treatment and the patient expired.The nurse asked if it is permitted to give vasopressors through the dialysis catheter purple lumen venous lumen.The nurse stated that the catheter was not saved.Ms&s informed the nurse that it is not contraindicated to give vasopressors through the venous purple lumen of the catheter.
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.There is sufficient information in the complaint description to substantiate that the device was not potentially causative or contributory to the patient's death.The patient had known sepsis prior to device placement and start of ccrt treatment.There is no alleged device malfunction or deficiency.The nurse was calling for guidance for infusing medication through the venous lumen of the device.The information requested and received is found in the product ifu which states that "¿the distal (purple) lumen is completely independent from the two dialysis lumens and may be used for intravenous therapy, power injection of contrast media, and central venous pressure monitoring.The distal lumen can also be accessed for blood draws and infusion of medications¿.

• Brand Name: POWER-TRIALYSIS SLIM-CATH PRECURVED EXTENSION SHORT-TERM DIALYSIS CATHETER FULL
• 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: 5764946
• Report Number: 3006260740-2016-00302
• Device Sequence Number: 3738
• Product Code: NIE
• UDI-Device Identifier: 00801741107207
• UDI-Public: (01)00801741107207(17)170228(10)REZH1074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 5865150
• Device Lot Number: REZH1074
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 09/16/2016
• 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: Death