MAUDE Adverse Event Report: 3M HEALTHCARE 3M MICROPORE PLUS+; PAPER TAPE

Catalog Number 1532S-1

Device Problem Migration (4003)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 09/06/2018

Event Type  Death  

Event Description

At 1707, 2 hours into a scheduled 3 hour hemodialysis treatment, pt was found unresponsive.Vs at 1655: b/p 119/66; pulse 85.When attempting to administer normal saline, it was noted the venous needle was dislodged, with approx 1.5 l blood loss.Pressure was held to cannulation site, and normal saline administered via arterial line; 911 was called, cpr was initiated and aed applied which advised no shock.A total of 3 liters of normal saline was administered during the resuscitation.Pt was discharged unresponsive from the clinic and transported to the hosp via ems, where the pt died.Upon inspection of the venous avf needle, it was noted that tape and gauze dressing were still intact on the fistula needle.The machine was sequestered and a functional test was performed.All required parameters passed.

• Brand Name: 3M MICROPORE PLUS+
• Type of Device: PAPER TAPE
• Manufacturer (Section D): 3M HEALTHCARE; st. paul MN 55144 1000
• MDR Report Key: 7901821
• MDR Text Key: 121586359
• Report Number: 7901821
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 3070387763160
• UDI-Public: (01)3070387763160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 1532S-1

Device Lot Number

• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2018
• Distributor Facility Aware Date: 09/06/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 79 YR
• Patient Weight: 73