MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ DURAPORE¿ SURGICAL TAPE; DURAPORE TAPE

Model Number N/A

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

Patient Problems Cardiopulmonary Arrest (1765); Hypovolemia (2243); Blood Loss (2597)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant 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 av fistula safety needle set back eye with clamp 15 gauge x1 inch.(b)(4) received from fresenius.End of report.

Event Description

An outpatient dialysis clinic reported the following information.Patient arrived to treatment alert and oriented.Pre-dialysis vital signs obtained: b/p: 152/77; pulse 73; resp 20; temp 97.6.Treatment was initiated at 13:21, and vital signs checked every 20 minutes.At 14:01.B/p was 128/68; pulse 75.Approximately 8 minutes later, the machine alarmed.The patient was found unresponsive with the tip of the venous needle dislodged.Tape was still intact on the patient's skin.Large amounts of blood were noted on the floor.Ebl 300-400ml.The venous line was clamped, and pressure applied to the venous cannulation site.Blood was returned via the arterial needle, and normal saline was administered via the arterial needle; approximately 800 ml normal saline was administrated.Oxygen was applied via mask at 3 lpm.Aed pads placed on chest, cpr initiated.911 was called.The patient started spontaneously breathing at 14:13.Vs upon discharge from facility: b/p 156/99; pulse 102; resp 23 temp 97.8.The patient was transported to the hospital via ems and admitted.Patient was transfused with 3 u prbcs during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019.

• Brand Name: 3M¿ DURAPORE¿ SURGICAL TAPE
• Type of Device: DURAPORE 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: 8279744
• MDR Text Key: 134260767
• Report Number: 2110898-2019-00018
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387007424
• UDI-Public: 30707387007424
• 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: 01/25/2019

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: 05/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 1538-1
• Device Lot Number: 2021 05 UD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 63