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 Problems Fall (1848); Cramp(s) (2193); Dizziness (2194)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the adverse event(s) of cramping, a higher than expected uf total, lightheadedness, fall and subsequent hip fracture.Follow-up with the outpatient clinic¿s bmt and the patient¿s rn revealed no 2008t hemodialysis system alarms were noted during treatment.Per the bmt, the event was attributed to probable operator error.The etiology of the cramping is unknown; therefore, causality cannot be firmly established.However, muscle cramping is a common complication of hd therapy, occurring in anywhere from 33 to 86 percent of hd patients.The etiology of the patient¿s lightheadedness, fall, and subsequent hip fracture cannot be definitively established; therefore, causality cannot be determined.Hemodialysis causes significant fluid shifts, and elderly dialysis patients are susceptible to hypotensive events during and following dialysis.Additionally, postural hypotension, symptoms of hypotension and falls are common in elderly hemodialysis patients.Based on the information available, the 2008t hemodialysis system can be disassociated from causing the event(s).There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency caused the event(s).Additionally, the 2008t hemodialysis system passed all uf testing, and was returned to service without requiring intervention.However, the 2008t hemodialysis system cannot be excluded from having a possible contributory role in the events.Given the uf removal was 500 ml¿s greater then expected and the lack of treatment record(s), there is insufficient evidence to exclude the 2008t hemodialysis system from the events.

Event Description

A user facility biomedical technician reported that a hemodialysis (hd) patient experienced cramping toward the end of their hd treatment.Reportedly the settings on the 2008t hemodialysis system were correctly entered, however ¿based on the patient¿s dry weight,¿ the ultrafiltration (uf) was higher than expected (4.0 liters instead of the expected 3.5 liters).The treatment record was not provided; however, there were no reported issues during treatment, prior to the patient complaining of cramping toward the end of treatment.The registered nurse (rn) stated no adjustments were made to the patient's uf goal, uf rate, or total treatment time.The cramping reportedly subsided after the patient¿s blood was returned, and no medical intervention was required.The patient completed treatment and is reportedly continuing hd treatment without any further problems.The rn stated there were no machine alarms during the treatment, and the patient utilized the same scale pre/post treatment.The 2008t hemodialysis system was sequestered following the event.The bmt confirmed no alarms occurred during treatment prior to the event.The bmt performed a uf id problem checklist, and the 2008t hemodialysis system was found to be operating within manufacturer specifications and passed all uf testing.The bmt reported the uf pump was calibrated as a precaution, however the uf discrepancy was likely caused by operator error.The 2008t hemodialysis system has been returned to service and is fully operational.Approximately twenty minutes after completing treatment, the patient was conversing with another patient in the clinic when they became lightheaded and fell (despite utilizing a walker).The patient was assisted to their feet and stated they felt fine.However, once the patient exited the building heading to the transport vehicle, it was reported that the patient was unable to bear weight (specifics not provided) on the hip.The patient was transported to the emergency room (er) for evaluation, and radiological testing revealed they sustained a minor hip fracture.Per the rn, the patient had recently been discharged from a nursing facility (dates/specifics not provided).The rn stated the patient's blood pressure was ¿normal¿ after the fall, however it was unknown if hd therapy caused or contributed to the lightheadedness or fall.

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.

• 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: 9903679
• MDR Text Key: 186519608
• Report Number: 2937457-2020-00564
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: 03/23/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 78