MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K W/O OLC & DIASAFE W/ HEPARIN PUMP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190303

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

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

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) and other device manufacturer mfr # 3002807350-2017-00007.The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

It was reported by user facility medwatch (b)(4) that a hemodialysis patient using a fresenius 2008k machine experienced blood loss of more than 300 ml.Certified clinical hemodialysis technician (ccht) was approaching patient to perform a 30 minute vital sign check 2 hours into a scheduled 4 hour in-center hemodialysis treatment and the fresenius 2008k machine started alarming.Patient was found unresponsive to verbal and painful stimuli and blood was noted on floor under patient's chair.Patient was placed in trendelenburg position.Venous needle was noted to be dislodged.The technician who did venipuncture followed taping policy with 3 pieces of tape in chevron-style.A different technician who did the 30 minute vital sign check saw that 1 piece of tape was intact on tubing to patient's arm, but the other 2 pieces of tape were off and venous needle was out of access.Pressure was applied to venous cannulation site.Arterial needle was secure and intact.Arterial blood was returned and 500ml normal saline was infused via the arterial line and oxygen was applied via face mask.Emergency medical service (ems) was called and an additional 500ml normal saline was given.Respiration was even and unlabored.Patient remained unresponsive to verbal and painful stimuli.Patient was transported to hospital via ems and admitted to ccu (coronary care unit).Patient had spent 4 days in ccu, and was then transferred to telemetry unit for additional heart monitoring for 3 day and was discharged on (b)(6) 2017.The patient has resumed normal hd treatment.

• Brand Name: 2008K W/O OLC & DIASAFE W/ HEPARIN PUMP
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7113788
• MDR Text Key: 94793934
• Report Number: 2937457-2017-01333
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 190303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82