MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-26 for STATIC AND DYNAMIC COMPLIANCE 22 E 777404-101 manufactured by Carefusion, Inc.
[46013469]
(b)(4). Results of investigation: the device was returned and evaluated by a carefusion factory service technician. The reported issue, of the sample pump being noisy and the gas was free flowing, was duplicated. The sample pump and the demand valve were replaced, which resolved the reported issue. The device was tested and passed to service specifications, then returned to the customer. The carefusion failure analysis laboratory performed a failure investigation on the suspect components but could not create the failure in the laboratory setting. A root cause of the reported failure could not be identified. The component was returned to the manufacturer for further evaluation. Upon receipt of the completed failure investigation, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[46013470]
The customer reported getting low volumes, having a noisy sample pump and gas free flow. She also stated that they had a (b)(6) patient diagnosed with testicular cancer with bilateral lung masses that had one pulmonary function test (pft) a month, for four months, starting in (b)(6) 2015 and the last one was in (b)(6) 2015. In (b)(6) the pft was showing normal lung values. The following months showed decreasing diffusion and restricted volumes with the last diffusion showing 53% in (b)(6). The patient was receiving aggressive chemotherapy called bleomycin which has a side effect of decreased lung function. It was advised that the patient discontinue chemotherapy based on his pft results. However, the clinician was concerned after having multiple module replacements in the previous months and she doubted the reliability of the results. It is unknown what happened to the patient because the patient did not return after (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031702-2016-00655 |
| MDR Report Key | 5682314 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-26 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-07 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-26 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-05-26 |
| Returned To Mfg | 2015-08-21 |
| Model Number | 22 E |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-26 |