MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for CIRCUIT 6FT HTD SINGLE LIMB ADULT 20/CS RT600-850 manufactured by Carefusion.
[37431106]
(b)(4)- initial emdr submission. Carefusion is awaiting the sample return from the customer. Multiple attempts have been made by customer advocacy to gain the sample. A ups label was provided to customer for the sample return, but to date the sample has not been received. The customer is unable to provide the lot number for the affected product. The customer states they are no longer using this product. If any additional information or if a sample becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[37431107]
Customer reported via email: "the issue is that we use f&p heater/humidifiers with our high-flow oxygen systems. The f&p temp probe that fits into the airlife rt600-850 circuit just above the heater port keeps popping out while in use because it's just a friction-fit connection and does not have a little latch that secures the probe. When that happens in use, the patient loses a significant part of the flow from the device and oxygen desaturation can occur. There was not any actual patient impact or harm related to this issue, the clinician was alerted by the spo2 alarm when the spo2 would go below 90%. This product is used when the patient is receiving high flow oxygen via nasal cannula. The clinician would then reconnect the temp probe into this circuit to fix the issue. I do not have the lot number, and we are no longer using this product. We have switched to an f&p circuit that provides a clip to keep the temperature probe from coming out of the circuit".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2016-00149 |
| MDR Report Key | 5391468 |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-15 |
| Date of Event | 2015-11-19 |
| Date Mfgr Received | 2016-01-15 |
| Date Added to Maude | 2016-01-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CIRCUIT 6FT HTD SINGLE LIMB ADULT 20/CS |
| Generic Name | CIRCULATOR, BREATHING-CIRCUIT |
| Product Code | CAG |
| Date Received | 2016-01-26 |
| Model Number | RT600-850 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-26 |