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

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.

• 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 Key: 7992612
• MDR Text Key: 124653083
• Report Number: 2110898-2018-00095
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Date: 03/28/2021
• Device Catalogue Number: 1532-1
• Device Lot Number: 2021-03 UD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR
• Patient Weight: 52