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); Blood Loss (2597)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full list of medical products: fresenius 2008 t hemodialysis machine; combiset hemodialysis tubing; 180 nre optiflux dialyzer; granuflo 2.0k, 2.5 ca, 1.0 mg, 100 dextrose; naturalyte 4000 rx12 bicarbonate (45x); fresenius 1000 ml normal saline; jms sysloc mini safety av fistula needle set 15 gauge x1 inch.Mw (b)(4) received from fresenius.Customer reported samples from the same lot number would be sent to 3m for analysis.No samples have been received to date.End of report.
Event or Problem Description
An outpatient dialysis facility reported the following information via a medwatch form.The reporter alleged a patient arrived at treatment; pre-dialysis vs obtained: b/p 153/77; pulse 86; resp 17; temp 97.8.Approximately 2 hours into the scheduled 4-hour hemodialysis treatment vs obtained were: b/p 97/52; pulse 84.The ultrafiltration was turned off and the patient's legs were elevated.The machine subsequently alarmed venous pressure and the blood pump stopped.The patient was lethargic and slow to respond verbally with the venous needle dislodged with the tape intact on the wings of the needle.Blood was noted to be flowing down the inside of the chair, a puddle of blood was under the chair.Ebl was 1 unit.Approximately 400 ml normal saline was administered, ems was called.Upon discharge from the facility via ems, patient was oriented with b/p 102/64; pulse 118.The patient was admitted to the hospital.1-unit prbc was infused in the er.

• 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: 8226188
• Report Number: 2110898-2019-00006
• Device Sequence Number: 16197405
• Product Code: KGX
• UDI-Device Identifier: 04046719352586
• UDI-Public: 04046719352586
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/08/2019

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: 06/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532-1
• Device Lot Number: 2021 06 UF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/08/2019
• 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 SYSLOC MINI SAFETY AV FISTULA NEEDLE SET
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80