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

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.

• 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 Key: 8741825
• MDR Text Key: 149625603
• Report Number: 1625685-2019-00058
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• 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 Number: 50-9900
• Device Lot Number: 0001293586
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization