MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2017-04-19 for ASSY, PAT CIR ADULT W / PEEP, SPUX10 29695-001 manufactured by Carefusion, Inc.
[73179556]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73179557]
Used circuit coming in for investigation. Failed at the peep/exhalation valve. Low peep pressures, loss of peep and low exhale volume return. Changed circuit "no harm or injury to the resident. Clinical changes that occurred: increase in etc02. Circuit passed the pre-use check. Intervention: circuit removed, resident bagged, new circuit obtained, tested and passed then connected to resident. Sample was sent to carefusion".
Patient Sequence No: 1, Text Type: D, B5
[113290515]
One open and contaminated circuit was received at the palm springs failure analysis lab. During bench test the sample was found working only intermittently with low peep pressures, loss of peep and low exhale volume. Further testing was not possible due to the contamination. The sample was sent to the decontamination facility in vernon hills and then sent to the quality engineers at the mexicali factory for final evaluation. Unfortunately the sample could not be completely cleaned residue remained in the tube. The device history record was reviewed and no issues were found. Two years of complaint trends were also reviewed and no trend was detected. Due to the residual contaminate no further functional testing could be performed. A visual inspection was performed but this was also very limited and unfortunately a root cause could not be determined. After a thorough review of the manufacturing procedure an improvement was identified. The procedure will be updated to clarify the correct method to perform the peep valve test. Personnel have been notified of the potential failure and further training has been done. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00324 |
| MDR Report Key | 6503765 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2017-04-19 |
| Date of Report | 2017-09-06 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-04-19 |
| 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 | MINDY FABER |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | CERRADA V NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSY, PAT CIR ADULT W / PEEP, SPUX10 |
| Generic Name | CIRCULATOR, BREATHING-CIRCUIT |
| Product Code | CAG |
| Date Received | 2017-04-19 |
| Returned To Mfg | 2017-03-30 |
| Catalog Number | 29695-001 |
| Lot Number | 0001045341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DR VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-19 |