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 02/25/2022

Event Type  Death  

Event Description

Pt arrived for regularly scheduled hemodialysis treatment.Pre treatment vital signs: bp 151/73, pulse 69, resp 18 temp 96.6.At approx 0818 hemodialysis treatment was initiated using the hemodialysis central venous catheter at a prescribed blood flow rate of 400 with a hemoclip securing the connection between the eve and venous bloodline.Within first several minutes of treatment initiation the rn discovered a pool of blood of approximately 100-300ml under patients chair.Blood pump was stopped by rn, blood loss was originating from venous bloodline/venous lumen connection site.Carotid pulse was palpable, hemodialysis treatment was terminated, blood was returned using arterial lumen of eve.At 0827 pt became unresponsive, ems called, cpr initiated; 0834 per automated cuff on hemodialysis machine: bp 110/17, p94.Ems arrived at 0840 and assume care of patient.Ems continued resuscitative efforts while transporting pt to hospital.Er representative informed facility clinical manager via telephone that pt expired at 0920.

• 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: 13678032
• MDR Text Key: 286675247
• Report Number: 13678032
• Device Sequence Number: 1
• Product Code: FJK
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• 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: 03/02/2022
• Distributor Facility Aware Date: 02/25/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 180 NRE OPTIFLUX DIALYZER,; COMBISET BLLOD LINES. ; FRESENIUS PRODUCTS: 2008T MACHINE, ; GRANUFLO 2.0K 2.5 CA 1.0MG 1000 DEXTROSE,; OTHER PRODUCTS: D GLIDEPATH LONG TERM HEMODIALYSIS CATHETER WITH ; PRELOADED STYLET
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White