MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-26 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[95726734]
The plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[95726735]
A technologist reported that per a hospital personal support worker (psw), a home hemodialysis (hd) patient encountered transmembrane pressure (tmp) alarms on the fresenius 2008k@home hd machine approximately 8-10 minutes after initiation of the hd treatment. The patient's blood pressure was 150/70 prior to the start of hd treatment. The blood pump was set to 300 ml/min. It was reported that the home hd patient passed out while connected to the machine. The patient's blood in the arterial side of the blood line appeared normal in color; however, the blood in the venous side of the blood line was a burgundy color. The patient lost a circuit of blood and was sent to the hospital. It was reported that the patient has fully recovered with no ill effects. Following the event, a fresenius medical care (b)(4) technician performed machine evaluation. The chlorine was checked at the carbon tanks and sample port of the hd machine and the results passed. In service mode, all tests passed for the blood pump, arterial pressure leakage, venous pressure leakage, level detector, conductivity, temperature, and diasafe filter. The technician checked the ultrafiltration (uf) pump and found the value at 23. 6 cc. The technician calibrated the uf pump to 24. 0 cc. The tmp was also found out of calibration at 0 mmhg tmp 50 and venous 1, and also at -250 mmhg tmp 199 and venous 1. After the technician did calibration, the value was in the required range. The electrical safety test was performed and the machine was put in heat disinfect mode. The technician found a loose pin on the blood pump rotor and replaced it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-01413 |
| MDR Report Key | 7145471 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-26 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2017-12-26 |
| 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 | 2017-12-26 |
| Model Number | 2008K@HOME |
| Catalog Number | 190395 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-12-26 |