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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)

Event Date 10/27/2018

Event Type  Injury  

Manufacturer Narrative

Full list of medical products: fresenius 2008 t hemodialysis machine; combiset hemodialysis tubing; 160 nre optiflux dialyzer; granuflo 2.0k, 2.5 ca, 1.0 mg, 100 dextrose; naturalyte 4000 rx12 bicarbonate (45x); fresenius 1000 ml normal saline; wingeater jms 15 gauge x1 inch fistula needle; heparin sodium (porcine) 6000 u bolus.Mw (b)(4) received from fresenius.Samples from the same lot number were received from the customer.The samples were tested for adhesion and met product specifications.End of report.

Event Description

An outpatient dialysis facility reported the following information via a medwatch form.Approximately 45 minutes into a scheduled 4 hours hemodialysis treatment, the machine alarmed arterial pressure.Staff found patient with venous fistula needle dislodged, with tape intact on wings of the fistula needle.A pool of blood was noted below the chair, which continued to the wall behind the chair.Chair was in semi-reclined position.Ebl 300 ml.Patient was unresponsive with erratic respiratory rate.Blood pressure was 112/60, pulse 60.Normal saline was administered through the arterial needle (total given 2.0l).Patient was placed in trendelenburg position and oxygen 10 l applied via nasal cannula.Patient was drowsy but responding to verbal stimuli.Ems was called, and patient was discharged with blood pressure 117/59, pulse 62, resp 18.One unit of prbc was administered in the er and patient was then discharged home.Patient returned to the facility for his next scheduled hemodialysis treatment on (b)(6) 2018.

• 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: 8123840
• MDR Text Key: 129022978
• Report Number: 2110898-2018-00109
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387763153
• UDI-Public: 30707387763153
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532-2
• Device Lot Number: 333A4X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2018
• 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
• Treatment: FRESENIUS 2008T MACHINE; JMS WINGEATER AV FISTULA NEEDLE 15 GAUGE, 1 INCH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94