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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

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CAREFUSION, INC PLEURX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING Back to Search Results
Catalog Number 50-9900
Device Problem Obstruction of Flow (2423)
Patient Problem Discomfort (2330)
Event Date 06/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial and final emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No sample was received from the customer.Consequently, no sample evaluation was performed in regards to the reported failure mode.Based on the complaint description, the most likely source for the incomplete drainage and potential leakage was due to the use of an alternate drainage bottle other than the recommended pleurx drainage bottle.However, with a sample to evaluate, the investigation was not able provide any further details regarding the reported failure mode.A device history record review for lot 0001293586 did not identify any manufacturing defects or issues that may have contributed to the reported failure.The device history record review did not identify any manufacturing issues which might have contributed to the failure mode.Additionally, the investigation was unable to confirm the reported failure mode through sample analysis.From the event description alone, the most probable root cause was the use of incompatible parts by the end user.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.Likewise, based on the reported failure description provided by the customer, the investigation noted the end user was attempting to perform a drainage procedure using an alternative drainage bottle other than the pleurx drainage bottles.The customer will be notified that the pleurx catheter is to be mated with and drained only with pleurx drainage bottles.The use of other drainage bottles are not authorized with the pleurx catheter system.
 
Event Description
Via email: patient received pleurx on (b)(6).Catheter was draining great with "pleurx brand bottles" 50-7510 for the 1st week in skilled facility.Patient was discharged and kindred hospice agency resumed care of the patient and was ordered to drain the pleurx they were told by their superiors to use the rocket brand bottles and that they were compatible and appropriate to be used on a pleurx catheter.Immediately after the 1st drainage they had problems draining the catheter.The output went from 1000ml+ on the pleurx bottle to 300ml or less with the rocket to then nothing at all.An attempt was made to flush the pleurx with a pleurx catheter access kit 50-7280 but this did not improve the output.Drainage has not been able to be achieve with the rocket bottle for 2 weeks leading to massive discomfort from the patient.The patient is returning to the hospital on (b)(6) for further evaluation.On (b)(6) 2019 additional information received: was there any patient harm or medical intervention required due to the event (i.E.Was the catheter changed)? dr.(b)(6) injected contrast to insure that the catheter was patent.He did pull a clot from the catheter with aspiration but was able to flush easy after.By sono the pt did not have ascites to drain.Dr.(b)(6) injected tpa 2mg in 10ml of normal saline to sit over night and ordered that the hospice staff flush and aspirate in the morning and continue to drain prn with the appropriate supplies that are compatible with the catheter.Were you able to drain with a pleurx bottle? we did not drain him when he came for evaluation because per sono he did not have any ascites.If the catheter is changed, will it be available for evaluation? if we have any further information and the catheter has to be removed, i will make sure you are aware and can receive it for evaluation.
 
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Brand Name
PLEURX PERITONEAL CATHETER & STARTER KIT
Type of Device
PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
MDR Report Key8741825
MDR Text Key149625603
Report Number1625685-2019-00058
Device Sequence Number1
Product Code PNG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number50-9900
Device Lot Number0001293586
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2019
Initial Date FDA Received06/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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