MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for 2008T HEMODIALYSIS SYSTEM W/BIBAG 190766 manufactured by Concord Manufacturing.
[186519608]
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.
Patient Sequence No: 1, Text Type: N, H10
[186519609]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00564 |
| MDR Report Key | 9903679 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2008T HEMODIALYSIS SYSTEM W/BIBAG |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-31 |
| Model Number | 190766 |
| Catalog Number | 190766 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |