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); Blood Loss (2597)

Event Date 11/27/2018

Event Type  Injury  

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 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
• 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: 8226188
• MDR Text Key: 132358363
• Report Number: 2110898-2019-00006
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 04046719352586
• UDI-Public: 04046719352586
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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 SYSLOC MINI SAFETY AV FISTULA NEEDLE SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80