MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-24 for Q2 CHECKMATE EXTENSION SET 9541 manufactured by Quest Medical, Inc..
[29824380]
The hospital ambulatory surgery supervisor (rn) reported an issue encountered with the q2 checkmate extension set. She reported that the crna observed that when patients are taken back into the or, there are issues with the iv ports becoming disconnected. The crna had told her this occurs on the anesthesia tubing line, and not the one that connects to the continuous iv tubing. The report stated they typically will discover the issue because fluids are leaking or blood is seen in the tubing. The fluids being administered at the time would be propofol, tranexamic acid, or some antibiotics. There have not been any patient complications reported as a result of the alleged malfunction. The hospital shipped a sample to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[31404392]
Visual evaluation of the device sample did not find any anomalies or cause for the reported complaint. The user had confirmed they were not tightening the cap after connecting the tubing to the checkmate. The instructions are indicated in the ifu. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2015-00093 |
| MDR Report Key | 5173761 |
| Date Received | 2015-10-24 |
| Date of Report | 2015-11-06 |
| Date of Event | 2015-09-28 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-10-24 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Q2 CHECKMATE EXTENSION SET |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2015-10-24 |
| Returned To Mfg | 2015-10-13 |
| Model Number | 9541 |
| Lot Number | 0488075A03 |
| Device Expiration Date | 2018-03-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-24 |