MAUDE Adverse Event Report: CAREFUSION ENFLOW CARTRIDGES; CARTRIDGES, STAND-ALONE, ENFLOW/LGZ

Model Number 980200EU

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Occlusion Within Device (1423); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2015

Event Type  Injury  

Event Description

Enflow system was in operation during a case.It appears a blood clot formed within the enflow cartridge causing an occlusion.As a result the enflow cartridge leaked through a split in the seam and blood leaked out into the operating theatre.The cartridge was disconnected from the system and replaced with a new cartridge.No ohs incident occurred with theatre staff as a result of the leak.Lot number information of the cartridge is currently not available.Updated information from subsequent customer communication indicates that during rapid re-infusion of blood using hand pump, it was noticed that fluid was leaking from seam of enflow cartridge (suspect partial occlusion-was told that fluid was still getting through).A blood clot was noticed at evaluation of fault with no alarm.The device was not triggered to turn off, and patient lost approximately 30ml of blood.The case continued without issue and there was no patient harm.

Manufacturer Narrative

(b)(4).The customer indicated that the device is available for return to carefusion.Shipment has been requested.If received, an evaluation of the device will be performed by carefusion.A follow-up mdr form will be sent with the evaluation results completed.

Manufacturer Narrative

The only corrected information and additional information is from the narrative text.Originally it was stated: "complaint (b)(4) the customer indicated that the device is available for return to carefusion.Shipment has been requested.If received, an evaluation of the device will be performed by carefusion.A follow-up mdr form will be sent with the evaluation results completed".It should have stated: "complaint (b)(4).The customer indicated that the device is available for return to carefusion.Shipment has been requested.If received, an evaluation of the device will be performed by carefusion.A follow-up mdr form will be sent with the evaluation results completed.This electronic submission report (2242551-2015-00026) has been generated to replace the manual submission mdr report (1423537-2015-00001) originally submitted by carefusion in carefusion complaint (b)(4).Manual submission mdr report (1423537-2015-00001) was initially received by the fda on 03/30/2015 for model # 980200eu (device: enflow cartridge).Manual submission mdr report (1423537-2015-00001) was a duplicate of an electronic submission by cardinal health received by the fda 01/09/2015 for model # 11443-012 (device: hot pack).This electronic electronic submission report (2242551-2015-00026) will replace the incorrect manual submission mdr report (1423537-2015-00001) from carefusion.

Manufacturer Narrative

Cfn-(b)(4).Additional information was added (lot number and manufacture date of device).The sample was received and an evaluation including functional testing of the device has been performed by carefusion.The leak was confirmed and the root cause is an adhesion failure in a localized area between the aluminum and the adhesive.The most probable cause for the bond failure could not be determined however may be from mishandling of the aluminum during assembly resulting in a weakened bond.The device history record (dhr) was reviewed for this serial number.This showed that this serial number passed all initial testing and no issues were identified that could have contributed to this observation.The dhf review concluded that all manufacturing steps were followed properly and the materials were within their allowable shelf-life.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: ENFLOW CARTRIDGES
• Type of Device: CARTRIDGES, STAND-ALONE, ENFLOW/LGZ
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan, guangdong 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4728024
• MDR Text Key: 5581594
• Report Number: 2242551-2015-00026
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 980200EU
• Device Lot Number: 14121085
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/24/2015; 06/05/2015; 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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
• Patient Outcome(s): Required Intervention