MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS HEMACLIP BLOOD LINE CONNECTOR CLIP FOR HEMODIALYSIS

Catalog Number 04-9100-1

Device Problems Disconnection (1171); No Fail-Safe Mechanism (2990)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841)

Event Date 09/07/2021

Event Type  Death  

Event Description

Pt presented for routinely scheduled hemodialysis treatment.Pretreatment vital signs were; weight (b)(6) kg, bp 159 / 77, pulse 84 respirations 16, temperature 97.7.Treatment initiated at 0627 at a blood rate of 400ml/min via a central venous catheter.Pt was routinely monitored approximately every thirty minutes with no issues reported.At 0824, the hand of the patient was near the blood line and central venous catheter connection site.After the patient was asked move his hand, it was noted the venous blood line was disconnected from the venous lumen of the central venous catheter.The previously attached hemaclip was not attached to the central venous catheter or blood line.The central venous catheter lumen and blood line were immediately clamped.An estimated 400-800 mls of blood were lost.Pt lost consciousness and pulse and resuscitative measures ensued.Pulse was regained while the patient was in the facility.Ems transported the patient to the local emergency department were resuscitative measures were again administered, but were unsuccessful leading to the expiration of the patient.

• Brand Name: FRESENIUS HEMACLIP BLOOD LINE CONNECTOR CLIP FOR HEMODIALYSIS
• Type of Device: HEMACLIP
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; waltham MA
• MDR Report Key: 12647404
• MDR Text Key: 277836219
• Report Number: 12647404
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04-9100-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Distributor Facility Aware Date: 09/07/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/14/2021
• 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
• Patient Age: 71 YR
• Patient Weight: 75