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 2017-02-08 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[66858855]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a fresenius post-market clinician performed a clinical investigation to identify a causal relationship between the hemodialysis treatment, the 2008k@home hd machine, and the patient expiration. No medical records, treatment sheets, or a death certificate were received for review. Based on the available information, a male patient with end stage renal disease (esrd) on home hemodialysis (hhd) expired in his home. The patient's spouse conveyed to the home hemodialysis nurse that the patient had passed in his sleep. The patient had a heart attack. The nursing staff reported that the patient's last treatment was on the morning of (b)(6) 2017. The nurse indicated that the hhd treatment was not related to the patient's death. There were no patient adverse effects experienced and no product problems were associated with that hhd treatment; however, no further treatment specific details were made available. There is no documentation available to indicate a causal relationship between any fresenius products and the patient's death. Furthermore, there were no allegations against any fresenius products being associated with the patient expiration.
Patient Sequence No: 1, Text Type: N, H10
[66858856]
A home hemodialysis (hhd) nurse reported that a patient passed away from an alleged heart attack at night while asleep. The patient had last dialyzed in the morning without any reported issues. The hhd nurse stated that the patient's death was not related to the hemodialysis (hd) treatment. The 2008k@home hd machine was the only fresenius manufactured product used during the patient's final hhd therapy performed the morning of the patient's passing. No allegation of a machine malfunction was reported. No parts are available to be returned to the manufacturer for evaluation. No additional information has been made available.
Patient Sequence No: 1, Text Type: D, B5
[68982052]
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 home hemodialysis (hhd) nurse who revealed that no device malfunctions were reported during the patient? S final hhd treatment. Furthermore, the hhd nurse stated that the death was not related to the 2008k@home hd machine. No further information was made available and 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
[68982053]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00087 |
| MDR Report Key | 6312902 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-02-08 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-02-24 |
| Device Manufacturer Date | 2008-12-18 |
| Date Added to Maude | 2017-02-08 |
| 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 | 2017-02-08 |
| Model Number | 2008K@HOME |
| 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 | 2017-02-08 |