MAUDE Adverse Event Report: CAREFUSION PLEURX DRAINAGE KIT 500ML 10/CS; APPARATUS, SUCTION, PATIENT CARE

Model Number 50-7500B

Device Problems Break (1069); Fluid/Blood Leak (1250); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

Carefusion received a phone call from a staff nurse who reported that whilst connecting a bottle to the patient's catheter, no clicking sound was heard to suggest it had connected and then the tip of the connector snapped off and got stuck within the patient's catheter.The catheter started leaking and they had to free drain 150ml.A cap has been fitted to close the catheter as with the tip stuck inside it keeps the port open.A sales representative has been in today and took photos.He managed to manipulate the tip out of the way to fit a new bottle which drained 250ml, however he has advised that a new catheter is required to ensure the tip does not become dislodged and move up the patient's line.The patient is too sick to undertake another implant for the new catheter so the doctors are now looking at other options. on (b)(6) 2014, the international contact ((b)(4)) provided the following additional information as obtained from the customer: a staff nurse drained the patient.Prior to use, there was nothing noted of the bottle and its components, including the access tip that would indicate a defect.When inserting the access dilator into the catheter, it was inserted straight in.When the nurse didn¿t hear the normal ¿click¿, the nurse slightly jiggled the access dilator to get it to click into place.The patient did not experience any symptoms or injury as a result of this issue.The pleurx catheter worked perfectly before the faulty bottle and it also worked ok after with a new bottle.The bottle sample is not available for evaluation.On (b)(6) 2014, the international contact ((b)(6)) indicated that it was confirmed that the patient passed away the previous week.The current catheter stayed in place until he passed; however, he was not symptomatic and did not require any further drainage after the fault.The customer is reporting this to the mhra.On (b)(6) 2014, the international contact ((b)(4)) provided the following information as received by the customer: the patient's date of death is (b)(6) 2014.The documented cause of death is metastatic squamous cell carcinoma of the lung.It is the opinion of all the physicians involved in the patient's care that the fault with the device did not contribute to his death.

Manufacturer Narrative

(b)(4).Investigation results: even though the physical sample was not received for evaluation, photos of the affected sample were received.During visual analysis of the photos, it was noted that the one piece access dilator was broken.Therefore, the reported condition was confirmed.A review of applicable manufacturing, inspection, and packaging procedures did not identify any issues that may have contributed to the reported condition.Verification of the condition of each one piece access dilator component prior to release is required in both manufacturing and inspection procedures.In addition, no issues were found during review of the internal production records for the lot indicated that could result in the reported condition.This includes review of all raw material and components used during the manufacture of the lot involved.The most probable root cause could not be determined, as a physical sample was not available for analysis and as during review of the applicable manufacturing, inspection, and packaging processes, no issues were found that could relate personnel, manufacturing method or materials to the reported condition.Although the root cause could not be determined without a sample being provided, the manufacturing plant will continue to monitor this issue to identify any adverse trend and/or need for further actions.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• Type of Device: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 203 LTD; zona franca las americas; km 22 e-1; santo domingo ; DR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3728689
• MDR Text Key: 16086848
• Report Number: 9680904-2014-00028
• Device Sequence Number: 1
• Product Code: DWM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 50-7500B
• Device Lot Number: 0000546957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 04/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1