MAUDE Adverse Event Report: 3M HEALTH CARE MICROPORE PLUS PAPER TAPE

Model Number 1532-1

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841); Blood Loss (2597)

Event Date 12/29/2017

Event Type  Death  

Event Description

Hemodialysis pt scheduled for regular dialysis treatment.Pre bp 132/83, pulse 76, resp 16, temp 98.6.Hemodialysis initiated via left upper avg utilizing 2 # 15 gauge wingeater needles.Treatment initiated at approx 1309 for a 4 hr treatment.At approx 1435 bp 150/71, pulse 80.At approx 1510, pt appeared to be in distress and placed in trendelenburg position, blood was noted under pt's chair.No reported audible machine alarm.Pt unresponsive, normal saline was administered via venous line, normal saline was noted seeping through venous line.Normal saline was then administered via arterial line, normal saline was noted seeping through arterial line.Tape and 2x2 gauze which was placed over both needle sites was removed.The arterial and venous needle were dislodged out of the pt's left upper avg, with the tape remaining attached to the pt's arm and to both needles; 911 called, oxygen provided, cpr was initiated.Ems arrived and took over care of pt, pt was transported to hospital and expired in the er.

• Brand Name: MICROPORE PLUS PAPER TAPE
• Type of Device: PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN
• MDR Report Key: 8199118
• MDR Text Key: 131502666
• Report Number: 8199118
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1532-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Distributor Facility Aware Date: 12/29/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 01/12/2018
• 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
• Treatment: COMBISET TRUFLOW, 2.0K, 2.5 CA, 1.0MG, 100DEXTROSE (B)(4); CRITLINE, F160NRE, NORMAL SALINE 1000ML BAG; FRESENIUS PRODUCTS - 2008T MACHINE, ; JMS A.V FISTULA NEEDLE SET WINGEATER 15 G X1"
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 82