MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

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

Patient Problem Pallor (2468)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse events of pale pallor and eyes rolling back, which required the administration of normal saline.The etiology of the patient¿s adverse events is unknown; therefore, causality cannot be established.Per the bmt, the 2008t hemodialysis system¿s uf pump required calibration, however the value was lower than the expected range, and therefore would remove less fluid from the patient, not more.While there is no objective evidence indicating the 2008t hemodialysis system caused the event, the device cannot be excluded from having a possible contributory role.Given the 2008t hemodialysis system required recalibration during post event functional compliance testing, there is insufficient evidence to definitively conclude what preempted the events.

Event Description

A clinical nurse manager (cnm) reported that a hemodialysis (hd) patient almost lost consciousness while dialyzing on a fresenius 2008t machine.The patient¿s treatment was initiated without issue, and while undergoing therapy (timeline not provided) the patient's eyes began to ¿roll back¿, and their face turned pale.The patient was given a bolus of intravenous (iv) normal saline (volume not provided), which successfully alleviated the symptoms (patient remained conscious).The cnm reviewed the hd treatment data and could not find documentation of when the patient¿s symptoms began or ended.The cnm stated the ultrafiltration (uf) function was never stopped/paused, nor were any machine alarms present during the treatment.The cnm reported there were no documented uf issues or hypotensive events reported/documented during treatment.The patient¿s hd treatment was not paused during the event, and the patient completed treatment without further issue.The cnm stated the patient continues to undergo hd therapy without further issue.It was reported that the patient is typically given a protein bar to eat during hd therapy, and it was confirmed a protein bar was given during this treatment.The cnm was unaware the machine was still being utilized since the event and reported several other patients have been treated on the same 2008t hemodialysis system without issue.The cnm stated following the call, the device would be pulled from service for further evaluation (specifics not provided).Follow-up with the clinic¿s biomedical technician (bmt) revealed the device required recalibration of the ultrafiltration (uf) pump.During post event functional compliance testing, the uf pump strokes were 23.7 ml, which is 0.2 ml below the allowable range of 23.9 ml ¿ 24.1 ml (successfully recalibrated).Although the uf pump required calibration, the bmt did not suspect the hd machine caused the events.The bmt stated the 2008t hemodialysis system¿s uf pump was below the expected range and would remove ¿less fluid¿ from the patient, not more.The remainder of the validation testing fell within manufacturer specifications, and the 2008t hemodialysis system was returned to service.

Manufacturer Narrative

Correction: b7; the patient's preexisting medical conditions were inadvertently omitted from the initial report.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9974475
• MDR Text Key: 188221827
• Report Number: 2937457-2020-00697
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 101