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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)
Date of Event	10/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 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.Mw (b)(4) received from fresenius.Analysis of production records completed, and no deviations or issues were found.Product met specification for every required testing point.Samples from the same lot number were received from the customer.The samples were tested for adhesion and met product specifications.
Event or Problem Description
An outpatient dialysis facility reported the following information via a medwatch form.Approximately 2.5 hours into a scheduled 4-hour hemodialysis treatment, the dialysis machine alarmed.Upon arrival to the chairside, the patient was found in the hemodialysis chair with her eyes closed.The venous fistula needle was noted to be dislodged with the tape intact; blood was pumping out of the venous needle; a pool of blood was noted under the chair approximately the size of the chair.The fistula lines were still taped to the patient's arm.The blood pump was stopped immediately, and normal saline was administered via the arterial fistula needle.911 was called.After approximately 400 ml normal saline bolus, the patient opened her eyes to verbal instruction.A total of 1.4 ml normal saline was administered.The patient was discharged via ems with a b/p of 129/61.Upon admission to the emergency room, her systolic blood pressure was in the 70's and she was bradycardic.1 liter of fluid and 2 units prbc were infused.She was admitted to the icu for hemorrhagic shock and discharged from the hospital on (b)(6) 2018, returning for her next scheduled in center hemodialysis treatment on (b)(6) 2018.

• Brand Name: 3M MICROPORE PLUS PAPER TAPE
• Common Device Name: MICROPORE¿ PLUS PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8123797
• Report Number: 2110898-2018-00108
• Device Sequence Number: 11241071
• Product Code: KGX
• UDI-Device Identifier: 04046719352586
• UDI-Public: 04046719352586
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532S-1
• Device Lot Number: 333C5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; JMS WINGEATER AV FISTULA NEEDLE 15 GAUGE, 1 INCH
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 119