MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-04-30 for MULTI ABSORBER ORIGINAL, DISPOSABLE ANBR02408 manufactured by Carefusion Vital Signs.
[4394337]
Leak in the pt circuit occurred during anesthetic. Bellows collapsed during ventilation. Flushed with 02 to supply fresh gas to get the bellows to inflate again. After the anesthetic, it was not possible to localize the leak. Tried to disassemble and assemble the pt system, replaced tubing and chalk block but this did not make any difference. Would not go through a system check because of the leak. The pt was anesthetized and planned. During the anesthetic, the anesthetic staff had to supply extra fresh gas to fill the bellows during ventilation as the volume in the bellows was low due to the leak. Troubleshooting revealed a defective chalk container. Visible cracks in the foremost chalk connector. The chalk block that was used during the anesthetic when the leak was noticed was discarded so am unable to fine out if this was also damaged. Replaced chalk block and checked the machine. System leak is now <100 ml/min, circuit leak shows approximately 170ml/min. Further troubleshooting also revealed a smaller leak in the manual bag; the bag was replaced. System check and circuit control carried out, carefusion acquired ge vital signs on (b)(6) 2013. A retrospective review of all complaints post acquisition was performed. This complaint was identified as being mdr reportable by cfn standards and is being submitted to fda.
Patient Sequence No: 1, Text Type: D, B5
[11802183]
Most probable cause is crack on the product causing leak. A 100% leak test in production line. Leakage cause (e. Crack due to external impact) happen during storage, transportation or use. Can be closed with existing inv (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242551-2014-00011 |
| MDR Report Key | 3836248 |
| Report Source | 06 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-02-10 |
| Date Mfgr Received | 2014-02-10 |
| Date Added to Maude | 2014-06-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 N. FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI ABSORBER ORIGINAL, DISPOSABLE |
| Generic Name | CO2 ABSORBERS |
| Product Code | BSF |
| Date Received | 2014-04-30 |
| Model Number | ANBR02408 |
| Catalog Number | NA |
| Lot Number | 8003138 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION VITAL SIGNS |
| Manufacturer Address | 20 CAMPUS ROAD TOTOWA NJ 07512 US 07512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-30 |