MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-06-10 for CARMEDA BIO-PROBE, PEDIATRIC CBDP-38P CB4627 manufactured by Medtronic Perfusion Systems.
[2057391]
Medtronic rec'd information that after open heart surgery, this pt's heart function did not improve, necessitating extracorporeal membrane oxygenation. It was reported that after 9 days on extracorporeal membrane oxygenation (ecmo), a leak was found coming from a crack on the flow probe cell which resulted in approximately 500 cc of blood loss, necessitating a blood transfusion. The circuit was changed out and 3 days after the change out, another leak was identified from a crack in the flow probe. It was reported that 700-800 cc of blood was lost, resulting in cardiac massage and a second blood transfusion. The pt still requires extracorporeal membrane oxygenation. This is the same pt as reported in medtronic pcr 554356 mfr report # 2184009-2011-00030.
Patient Sequence No: 1, Text Type: D, B5
[9010683]
(b)(4): analysis: visual inspection showed a large 1. 25 inch long crack on the probe body. Further inspection showed white fog around both connector ends at second barb location. Performance analysis: pressure integrity testing confirmed leak from cracks in probe body. Damage was consistent with the use of a non-compatible solution used, possibly used to wet the tubing prior to connection. Device history review found the product met specifications when released for distribution. Conclusion: the clinical observation was confirmed. The root cause was determined to be caused by operational context. Damage was consistent with use of a non-compatible solution on the probe, such as alcohol; in addition, the device was used beyond the indicated time (6 hours) for extracorporeal bypass support per labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2011-00036 |
| MDR Report Key | 2130679 |
| Report Source | 05,07 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-13 |
| Date of Event | 2011-05-04 |
| Report Date | 2011-05-13 |
| Date Reported to Mfgr | 2011-05-13 |
| Date Mfgr Received | 2011-05-13 |
| Device Manufacturer Date | 2010-08-31 |
| Date Added to Maude | 2011-06-27 |
| 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 | MIKE GAFFNEY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635265629 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARMEDA BIO-PROBE, PEDIATRIC |
| Product Code | DPT |
| Date Received | 2011-06-10 |
| Returned To Mfg | 2011-05-24 |
| Model Number | CBDP-38P |
| Catalog Number | CB4627 |
| Lot Number | 11097967 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DRIVE BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-10 |