MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-05-27 for CATHETER IUPC EXTERNAL KOALA UNKNOWN manufactured by Clinical Innovations Llc.
[2148295]
Admitted to ob unit on (b)(6) 2011 at 38. 5 weeks gestation for scheduled induction due to large fibroids. Pt with 5'6", and (b)(6) admitted to ob unit at 0813. Pitocin started at 0920. Had srom (clear) at 1114. Epidural started at 1400. At 1516, sve by ob physician noted 4-5/70%/-2. At 1517, iupc and fetal scalp electrode inserted by ob physician. Blood noted in iupc and removed by ob physician. New iupc inserted. At 1519, fetal bradycardia noted. Developed prolonged decelerations. Had emergent c-section delivery at 1534. During c-section noted large lower uterine segment fibroids, velamentous insertion of umbilical cord, small amount of dark blood within uterus, no large amount, no bright red bleeding; small for gestational age-appearing placenta. Infant required resuscitation as had no pulse. Was transported to nicu at 1810. Required resuscitation attempt again and was pronounced dead at 2245. Infant autopsy indicates umbilical cord laceration that led to hypovolemic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2111695 |
| MDR Report Key | 2111695 |
| Report Source | 99 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-04-09 |
| Date Facility Aware | 2011-05-16 |
| Report Date | 2011-05-20 |
| Date Reported to FDA | 2011-05-20 |
| Date Reported to Mfgr | 2011-05-20 |
| Date Added to Maude | 2011-06-07 |
| 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 |
| 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 | CATHETER IUPC EXTERNAL KOALA |
| Generic Name | IUPC |
| Product Code | HFN |
| Date Received | 2011-05-27 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS LLC |
| Manufacturer Address | 747 WEST 41705 MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-05-27 |