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

Model Number N/A

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 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 wingeater safety av fistula needle set 15 gauge x1 inch be with clamp.Mw (b)(4) received from fresenius.End of report.

Event Description

Patient arrived for treatment alert and orientated.Pre-dialysis vital signs obtained: b/p: 187/62; pulse 72; resp 18; temp: 98.0.At 19:59, the patient was observed with the access uncovered and no bleeding from site.At 20:01, approximately 2.5 hours into the scheduled 4 hour hemodialysis treatment, during the q 30 minute vital signs check, the patient was noted to be slow to respond.Vs obtained: b/p 47/26; pulse 64.Patient's venous needle was dislodged with tape intact on the wings of the needle.Large amounts of blood were noted on both the chair and the floor.Elb 500 ml.The venous line was clamped, and pressure applied to the venous cannulation site.Normal saline was administered via the arterial needle.911 was called.After infusion of approximately 1000 ml normal saline, b/p: 126/53; pulse 64; patient was alert and oriented.Upon discharge from the facility via ems; the patient was alert and oriented with b/p 110/50; pulse 67; resp 18.The patient was transported to the hospital and admitted.The patient returned to the facility for hemodialysis on (b)(6) 2018.

• Brand Name: 3M MICROPORE PAPER TAPE PLUS
• 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; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8257683
• MDR Text Key: 133541130
• Report Number: 2110898-2019-00012
• 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: 01/17/2019

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: 10/06/2021
• Device Model Number: N/A
• Device Catalogue Number: 1532S-1
• Device Lot Number: 333GKY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 88