MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-01-11 for GAMBRO PRISMA UNKNOWN manufactured by Gambro.
[2427515]
Continuous dialysis was initiated on (b)(6) 2011. Initial set-up of the gambro prisma crrt machine was uneventful. During therapy from (b)(6) 2011 through (b)(6) 2012, the machine had multiple self-test failures, but were resolved with help through phone calls to technical support. The two failure codes were 00c0-filter and effluent pod and 0040-filter pressure pod. After several days of interrupted therapy, a second machine was brought in, primed, and therapy restarted on (b)(6) 2012. The error codes continued to occur and technical support continued to provide guidance, which appeared to resolve the errors. At approximately 12:30 on (b)(6) 2012, the patient was unresponsive in pea. We are unable to determine at this time whether the machine malfunction contributed to the patient's death, as the patient had a complex medical history.
Patient Sequence No: 1, Text Type: D, B5
[9585264]
At this time it is unclear whether the device errors are related to the patient death, but because we cannot rule this out, are reporting same. In response to section f, there were two devices that contained the same errors. Because the manufacturer retrieved these devices before we could complete reporting, we do not have information as to which device was being utilized at the time of the patient's death, and have thus, included serial numbers for both.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2417674 |
| MDR Report Key | 2417674 |
| Report Source | 99 |
| Date Received | 2012-01-11 |
| Date of Report | 2012-01-09 |
| Date of Event | 2012-01-05 |
| Date Facility Aware | 2012-01-05 |
| Report Date | 2012-01-09 |
| Date Reported to FDA | 2012-01-10 |
| Date Reported to Mfgr | 2012-01-10 |
| Date Added to Maude | 2012-01-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMBRO |
| Generic Name | PRISMA CRRT MACHINE |
| Product Code | FII |
| Date Received | 2012-01-11 |
| Returned To Mfg | 2012-01-06 |
| Model Number | PRISMA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Brand Name | GAMBRO |
| Generic Name | PRISMA CRRT MACHINE |
| Product Code | FII |
| Date Received | 2012-01-11 |
| Returned To Mfg | 2012-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-01-11 |