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 2020-01-14 for COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY C-HDCSYJ-1201J-LSC-IHI-CCT-A manufactured by Cook Inc.
[188857515]
Common name: catheter, hemodialysis, non-implanted. Product code: mpb. (b)(6). Occupation: unknown. Pma/510(k) #: k161504 (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[188857516]
It was reported that cook turbo-flo hd hemodialysis catheter tray catheters are either cracking at the hub or down the extension tubing on either the access or return line. The user facility has reported that this has occurred at least six times. Patients using these devices are on continuous renal replacement therapy (crrt). The machines used with these devices are "ringing off 'air in blood' alarm" and are reportedly drawing air into the machine as a result of catheter failure. Consequently, the patients have "needed to be taken off the prismaflex, rewired for another line and then put back on the machine". It was stated that "this is a safety issue with air entering the machine". The patients have reportedly experienced delayed treatment as they had to be re-placed on the machine once another line was inserted. This report references the instances of catheters cracking down the extension tubing on either the access or return line. The report with mfg. Report reference #: 1820334-2020-00105 references the instances of catheters that have cracked at the hub. Additional information regarding the patients, events, and devices has been requested but is unavailable at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00106 |
| MDR Report Key | 9586706 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2019-12-22 |
| Date Added to Maude | 2020-01-14 |
| 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 | UNK JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY |
| Product Code | MPB |
| Date Received | 2020-01-14 |
| Catalog Number | C-HDCSYJ-1201J-LSC-IHI-CCT-A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |