MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2013-03-12 for CATH LAB MONITORING KIT 46096-26 manufactured by Icu Medical, Inc..
[3248614]
Medsun report received reporting reading errors with use of one 46096-26 cath lab monitoring kit. The report states "manifold kit was opened, prepped, and set up per protocol and manufacturing standards. Upon 'zeroing' of transducer, modified square wave test was performed by covering end of manifold tubing with finger. No change in pressure noted. Transducer was replaced and reconnected to pressure monitoring wire. The pressure transducer began to work". There were no reported adverse patient consequences. Although requested, additional event/ device set-up information and device return status as of this date have not been provided. Mfr's investigation: a review of the 46096-26 direction for use provides the detailed steps for set-up, pre-testing the transducer zeroing, leveling and calibrating functionality for air-fluid interface. The medsun description describing the facility's "modified" test approach does not appear to identify relevant set-up requirements, component settings and monitor's set-up instructions.
Patient Sequence No: 1, Text Type: D, B5
[10656484]
Method - a review of the manufacturing lot build records for the reported lot # 2545111 (manufacture date 09/01/2012) shows (b)(4) units were manufacturer tested, inspected and released. There were no exception documents generated during the manufacturing build cycles. Conclusion: the involved 46096-26 cath lab kit has not been returned for analysis and confirmation. The exact cause(s) of the reported issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025816-2013-00095 |
| MDR Report Key | 3040414 |
| Report Source | 00,05,06,07 |
| Date Received | 2013-03-12 |
| Date of Report | 2013-05-06 |
| Date of Event | 2013-04-24 |
| Date Facility Aware | 2013-04-24 |
| Report Date | 2013-05-06 |
| Date Reported to FDA | 2013-06-11 |
| Date Reported to Mfgr | 2013-06-27 |
| Date Mfgr Received | 2013-06-27 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-10-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY SCESNY |
| Manufacturer Street | 4455 ATHERTON DR |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH LAB MONITORING KIT |
| Generic Name | CATH LAB MONITORING KIT |
| Product Code | OES |
| Date Received | 2013-03-12 |
| Model Number | 46096-26 |
| Catalog Number | 46096-26 |
| Lot Number | 2545111 |
| ID Number | PR#19931 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-12 |