MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-11 for PERMCATH 8815543001 manufactured by Covidien Mfg Solutions S.a..
[96959134]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[96959135]
According to the reporter, the device was used with a pediatric set pump. The dialysis generator issued a pressure alarm. It was noticed that the blood circuit was full of air. After clamping the venous line, it was noticed that the compresses around the catheter was full of blood. The catheter clamps were immediately closed. After opening the compresses the customer noticed the screw thread of the arterial line was completely mismatched. There was loss of a complete blood circuit (150 ml) for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2018-00014 |
| MDR Report Key | 7181933 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-08-07 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2018-01-11 |
| 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 | JACQUELINE ST. PIERRE |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524938 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE 2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMCATH |
| Generic Name | CANNULA, A-V SHUNT |
| Product Code | FIQ |
| Date Received | 2018-01-11 |
| Model Number | 8815543001 |
| Catalog Number | 8815543001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE 2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-01-11 |