MAUDE Adverse Event Report: MEDTRONIC OF CANADA DISTRIBUTION CENTER MAHURKAR LEGACY 13.5FRX19.5CM SE ACUTE DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON- IMPLANTED

Lot Number 1803100136

Device Problem Volume Accuracy Problem (1675)

Patient Problem Overdose (1988)

Event Date 12/06/2018

Event Type  malfunction  

Event Description

The patient presented with stroke.In this setting a catheter was inserted for treatment.On the morning of (b)(6) 2018, the heparin assay was elevated (0.52 iu/ml) for unclear reasons as the only systemic heparin that the patient received was a single 5000u subcutaneous dose.The catheter dwell was aspirated and re-dwelled with heparin 5000 units/ml according to medtronic's recommended port volume for the arterial port of 1.6ml and the venous port of 1.7ml.A heparin assay was drawn just prior to the re-dwell procedure.The re-dwell was performed in the presence of 2 rns validating correct port, port volume, heparin dose and procedure.Repeat heparin assay was checked 3 hours after re-dwell and was substantially elevated at 1.63.The catheter was removed, carefully examined and no fracture or breach in the catheter was identified.After removal, the catheter lumens were flushed to determine if they accepted the required volume.The arterial port should have been dwelled with 1.6ml.When flushed it only accepted 1.3ml.The venous port should have accepted 1.7ml and only accepted 1.4ml.Therefore the patient received 0.6ml of dwell systemically or a 3000u bolus of heparin.

• Brand Name: MAHURKAR LEGACY 13.5FRX19.5CM SE ACUTE DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, NON- IMPLANTED
• Manufacturer (Section D): MEDTRONIC OF CANADA DISTRIBUTION CENTER; manfield MA
• MDR Report Key: 8550887
• MDR Text Key: 143397791
• Report Number: MW5086172
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 8888135194
• UDI-Public: 8888135194
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1803100136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 69