MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

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

Patient Problems Bradycardia (1751); Loss of consciousness (2418); Blood Loss (2597)

Event Date 10/20/2018

Event Type  Injury  

Manufacturer Narrative

On-site evaluation: a fresenius regional equipment specialist evaluated the hd machine on site on 11/13/2018. Four self-tests were performed and passed. Alarms were created and the machine responded appropriately. Pressures and calibrations were checked and found to be within normal limits. A plant investigation is in process and a supplemental mdr will be filed when completed.

Event Description

A hemodialysis (hd) clinic reported a needle dislodgement with an adverse event to the patient. The patient is female and 66 years of age with a history or end stage renal disease (esrd). The patient was on hd treatment and experienced a needle dislodgement resulting in blood loss, loss of consciousness and bradycardia. The patient was approximately two and a half hours into a scheduled four hour hd treatment when the fresenius 2008t hd machine alarmed. The patient was discovered by the registered nurse (rn) in the chair with their eyes closed. The venous fistula needle (not a fresenius product) was noted to be dislodged with the tape intact on the fistula wings and blood was pumping out of the venous needle. A pool of blood was noticed under the chair approximately the size of the chair. The fistula lines were still taped to the patient¿s arm. The blood pumps were stopped immediately and normal saline was administered via arterial fistula needle. Emergency medical services (ems) were called. A 400ml normal saline bolus was administered, and the patient opened their eyes and responded to verbal commands. A total of 1. 4l of normal saline was administered at the clinic. The patient was transported to the hospital via ems with a blood pressure of 129/61. Upon arrival to the emergency room (er) the patient¿s systolic pressure was in the 70s (bradycardic). The patient was treated with 1l fluids (unspecified) and 2 units of packed red blood cells (prbc). The patient was admitted to the intensive care unit (icu) with a diagnosis of hemorrhagic shock. The hospital course is unknown and the patient was discharged from the hospital on (b)(6) 2018. The patient returned for regularly scheduled hd treatment on (b)(6) 2018 with no reported issues. Prior to the alarm, the patient was checked approximately seven minutes prior to the needle dislodgement. At 0853 hours the patient¿s bp was 150/74, pulse 64, blood flow rate 0, dialysis flow rate 700, arterial pressure 27, venous pressure 170, ultrafiltration (uf) rate 0 and fluid removed was 1535ml (unknown what parameters the machine was set at prior to start of hd treatment). No interventions were performed at that time. The machine underwent annual maintenance and self-testing, passed, and was placed back in service. It is unknown what alarm was sounding at the time of the needle dislodgement and the rn reported that the blood pump was still running when she arrived chairside. The patient blood loss, loss of consciousness and bradycardia with subsequent hospitalization for hemorrhagic shock was a direct result of the patient¿s venous fistula needle (not a fresenius product) dislodgement. There is no documentation or allegation that the 2008t machine or any other fresenius product malfunctioned or did not perform as intended. The machine did alarm when the adverse event occurred, however, the rn could not determine which alarm was sounding. It is unknown what may have occurred to cause the needle to dislodge approximately 2. 5 hours after initiation of treatment. Additional patient and event information was requested, but has not been provided.

Manufacturer Narrative

A fresenius regional equipment specialist (res) performed an on-site machine evaluation during an associated field service call and verified that the 2008t hemodialysis (hd) machine passed self-tests and functional checks, performed appropriately and was returned to service. A serial number search in the complaint handling system found one associated complaint number, subsequently closed as a non-complaint, with the issue of device evaluation within 90 days of the notified date.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8074908
• MDR Text Key: 127282920
• Report Number: 2937457-2018-03398
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 11/15/2018 Patient Sequence Number: 1

Treatment

FRESENIUS BLOODLINES; FRESENIUS DIALYSIS CONCENTRATES; FRESENIUS DIALYZER; FRESENIUS SALINE; FRESENIUS BLOODLINES; FRESENIUS DIALYSIS CONCENTRATES; FRESENIUS DIALYZER; FRESENIUS SALINE