• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M HEALTH CARE 3M MICROPORE PLUS PAPER TAPE; MICROPORE¿ PLUS PAPER TAPE Back to Search Results
Catalog Number 1532-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Blood Loss (2597)
Event Date 09/21/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical product(s): full list of medical products: fresenius 2008 t hemodialysis machine; combiset hemodialysis tubing; 160 nre optiflux dialyzer; granuflo 2.0k, 2.25 ca, 1.0 mg, 100 dextrose; naturalyte 4000 rx12 bicarbonate (45x); fresenius 1000 ml normal saline; wingeater jms 15 gauge x1 inch be with clamp fistula needle.(b)(6).The sample testing showed the product met specification.The facility reported the patient's "arm was noted to have dropped into the chair, causing tension on the venous line".Tension on the venous line was most likely the cause of the venous needle dislodgement.3m contacted the facility for investigation of the reported event on 2oct2018.The facility supervisor reported the patient had been hospitalized from (b)(6) 2018 following the adverse event.The patient was reportedly hemodynamically stable and in stable condition when discharged to home.On (b)(6) 2018, the patient was short of breath and called 911 from home.The ambulance arrived, and the patient suffered a cardiac arrest and died.The facility supervisor reported the cardiac arrest was unrelated to the venous needle dislodgement.End of report.
 
Event Description
An outpatient dialysis center reported the following event.At 12:35, approximately 1 hour 30 minutes into scheduled 3.5 hour hemodialysis treatment, patient's b/p was 90 systolic and patient was difficult to arouse.Vs at 12:06: b/p: 118/62; pulse 87.Blood was noted under patient's chair.The blood pump was stopped, and access was assessed.Arm was noted to have dropped into chair, causing tension on venous line.The venous fistula needle was noted to be dislodged.Pressure was held to venous site; blood was returned, and normal saline was administered via the arterial fistula needle.Oxygen was applied via nasal cannula.911 was called.Patient did not arouse with painful stimuli; patient appeared to have agonal breaths with no pulse.Cpr was initiated with one round administered before patient opened eyes and mumbled to staff.Palpable pulse and apical heart sounds auscultated.Approximately 800 ml normal saline administered.Hemostasis achieved on venous cannulation site.Patient transported to er via ems.Admitted to hospital and transfused with 2 units packed red blood cells.Upon inspection of the venous avf needle, it was noted that the tape and gauze dressing were still intact on the fistula needle.A follow-up report was received from the outpatient facility on (b)(6) 2018 with additional information: the patient was discharged from the hospital on (b)(6) 2018 and sustained a cardiopulmonary arrest in her home on (b)(6) 2018, resulting in her death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
3M MICROPORE PLUS PAPER TAPE
Type of Device
MICROPORE¿ PLUS PAPER TAPE
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
Manufacturer (Section G)
3M DEUTSCHLAND GMBH, WERK
manufacturing medical devices
edisonstrasse 6
kamen, 59174
GM   59174
Manufacturer Contact
dianne gibbs
3m center building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517379117
MDR Report Key7992612
MDR Text Key124653083
Report Number2110898-2018-00095
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2021
Device Catalogue Number1532-1
Device Lot Number2021-03 UD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Initial Date Manufacturer Received 10/02/2018
Initial Date FDA Received10/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
Patient Age57 YR
Patient Weight52
-
-