MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-02-22 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[68064085]
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity. Clinical investigation: based on information captured within the complaint file, it was reported that a male, end stage renal disease (esrd) patient on home hemodialysis (hhd) expired at home. The patient's final hhd treatment concluded at 7:00 am on the morning of (b)(6) 2017. Reportedly, the patient's spouse returned home at 6:30 pm on (b)(6) 2017, and found the patient had passed away. The spouse told the nurse manager that the patient had been having chest pains and suspect heart problems over the last little while and was not seeking further attention. The medical examiner stated that the patient died of natural causes, and no autopsy was scheduled. The patient's medical history is not known. There is no documentation to indicate that a causal relationship exists between the 2008k@home hemodialysis (hd) machine and the patient's death. Furthermore, there is no allegation against any fresenius products and the patient expiration.
Patient Sequence No: 1, Text Type: N, H10
[68064086]
The home dialysis coordinator for the user facility reported that a patient's spouse found that the patient had passed away at 6:30pm on (b)(6) 2017. The patient's final treatment was completed at 7:00 am on the morning of (b)(6) 2017. Therefore, the patient was not dialyzing when the death occurred. The medical examiner has ruled the patient's death was from natural causes, and unrelated to the dialysis treatment. No autopsy was scheduled. The patient's spouse noted that the patient had "chest pains and suspect heart problems over the last little while and was not seeking further attention. " a fresenius regional equipment specialist (res) performed annual preventive maintenance (pm) on the home hemodialysis (hd) machine several hours after the patient completed their final hd therapy on (b)(6) 2017; no device problems were identified or observed during the evaluation. No parts are available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[69590450]
The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. Follow-up information was provided by the patient's caregiver who revealed that no device malfunctions were reported during the patient? S final hhd treatment. Furthermore, a coroner ruled that the death was not related to the patient's hemodialysis treatment on the 2008k@home hd machine. A fresenius regional equipment specialist (res) performed annual preventive maintenance (pm) on the home hemodialysis (hd) machine several hours after the patient completed their final hd therapy on (b)(6) 2017; no device problems were identified or observed during the evaluation. The current status of the hd machine is not known. 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 deviations or non-conformances during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the material and process controls were within specification. The investigation into the cause of the patient incident was not able to confirm an issue which would have resulted in the adverse event. However, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Patient Sequence No: 1, Text Type: N, H10
[69590451]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00122 |
| MDR Report Key | 6350608 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-02-22 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2008-10-21 |
| Date Added to Maude | 2017-02-22 |
| 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 | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | 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 MACHINE,SHORT CAB,OLC/DP,HP |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2017-02-22 |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| 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 | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-02-22 |