STATIC AND DYNAMIC COMPLIANCE 22 E 777404-101

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number2031702-2016-00655
MDR Report Key5682314
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-05-26
Date of Report2015-08-07
Date of Event2015-08-07
Date Mfgr Received2016-05-02
Date Added to Maude2016-05-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL RITTORNO
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149227830
Manufacturer G1CAREFUSION, INC
Manufacturer Street1100 BIRD CENTER DR.
Manufacturer CityPALM SPRINGS CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTATIC AND DYNAMIC COMPLIANCE
Generic NameCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2016-05-26
Returned To Mfg2015-08-21
Model Number22 E
Catalog Number777404-101
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-05-26

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