MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-28 for 2008K@HOME HEMODIALYSIS SYSTEM 190828 manufactured by Concord Manufacturing.
[181535703]
Clinical review: there is a temporal relationship between hd treatment utilizing the 2008k@home hemodialysis system and the patient suspected air embolism with transport to the local hospital. However, there is no documentation in the complaint file to show a causal relationship between use of the machine and the patient event. Additionally, the machine evaluation was completed, and no issues were found. An air embolism was not confirmed, and it is unknown if any medical intervention was received; however, based on the time the patient spent at the hospital it is likely the patient problem was not complex requiring invasive intervention. The patient has also returned to hd therapy utilizing the same machine without any further issues. The 2008k@home machine user? S guide alerts the patient that the air detector alarm is a critical safety feature which will alert the user of potential air in the bloodline. The air detector will alert when the level of blood or saline in the venous drip chamber is too low. Failure to follow the instructions in the user? S guide can result in serious injury or death. Based on the available information it is unknown if the patient experienced an adverse event with medical intervention. Additionally, the patient? S machine evaluation did not find any machine issues and the patient has resumed treatment on the same machine. Therefore, the 2008k@home hemodialysis system can be excluded as causing the event with patient emergency transport to the local hospital. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[181535704]
It was reported that a patient on hemodialysis (hd) utilizing the 2008k@home hemodialysis system was urgently hospitalized for a possible air embolism. The patient returned home four hours later. The machine was checked the following morning. The blood serum level in the venous chamber was 10mm above the level detector door; however, the patient reported that the level in the venous chamber was fine all the way until disconnect. The level calibration checked both channels and the calibrations were fine. The blood pump was found to have no problems. The machine passed all tests. No problems were found with the machine. Additional information confirmed the patient was 2 hours into a 3. 5 hour hd treatment when an emergency was encountered. No signs or symptoms were reported. The patient reportedly disconnected from the machine per emergency disconnect procedures. The patient was transported to the hospital via emergency medical services (ems). It is unknown what testing or evaluation was completed at the hospital or if any medical intervention was received. The patient was discharged four hours after arrival. There is no confirmation that the patient was diagnosed with an air embolism. The patient reported no unusual alarms were received during the treatment and no foam was seen in the blood in the venous or arterial blood chamber. There were no level detector alarms. It is suspected the patient utilizes an arteriovenous (av) fistula as the hd access, but that was not confirmed. A photo documented that the level in the venous chamber was within normal limits. The patient has returned to hd therapy utilizing the same machine with no additional issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00406 |
| MDR Report Key | 9769296 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2008-12-18 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| 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 | 2008K@HOME HEMODIALYSIS SYSTEM |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2020-02-28 |
| Model Number | 190828 |
| Catalog Number | 190828 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-28 |