MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-12-07 for MCB 212 DUAL TANK MIX & DELIVERY BICARB SYSTEM manufactured by Mar Cor Purification.
[129751916]
The facility reported the incorrect concentration of bicarbonate solution from the mcb 212 bicarb system was delivered from the distribution tank to the loop and to patients. The concentration of bicarbonate solution was diluted due to an operator leaving a valve open while cleaning the mix tank during patient treatments. (twelve (12) patients were receiving dialysis treatment at the time. The facility reported patients were experiencing cramping. According to the facility, the bicarbonate solution in the distribution tank was accidentally diluted as an operator left a valve open while they were cleaning the mix tank during patient treatments. Ro water from the mix tank combined with the outgoing bicarb solution from the distribution tank causing more unused fluid from the loop to be returned to the distribution tank, thus further diluting the bicarb solution. This resulted in the dialysis machines alarming for low level. Video footage from the facility confirmed the solution level increase in the distribution tank and they observed one of the staff members cleaning the mix tank and not properly shut off the valves. The mcb 212 bicarb system user manual clearly warns users not to disinfect the mix tank while dialyzing patients as possible harm could occur. The facility reported to have retrained their staff to prevent this issue from reoccurring. Mar cor purification regulatory followed up with the facility and they reported a nurse followed up with all the patients receiving dialysis at the time and confirmed they were all doing better. No additional medical attention was sought. This complaint will continue being monitored in mar cor purification's complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[129751917]
The facility reported the incorrect concentration of bicarbonate solution from the mcb 212 bicarb system was delivered from the distribution tank to the loop and to patients. The concentration of bicarbonate solution was diluted due to an operator leaving a valve open while cleaning the mix tank during patient treatments. Twelve (12) patients were receiving dialysis treatment at the time. The facility reported patients were experiencing cramping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2018-00003 |
| MDR Report Key | 8144049 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-11-14 |
| Date Added to Maude | 2018-12-07 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14550 28TH AVE N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE N. |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCB 212 DUAL TANK MIX & DELIVERY BICARB SYSTEM |
| Generic Name | BICARB SYSTEM |
| Product Code | FIN |
| Date Received | 2018-12-07 |
| Model Number | MCB 212 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVE N. PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-07 |