MAUDE Adverse Event Report: CAREFUSION CANNULA SOFT ADULT W/25FT TB 25/CS; CANNULA, NASAL, OXYGEN

Model Number SFT2625

Device Problems Coiled (1098); Kinked (1339)

Patient Problems Toxicity (2333); Low Oxygen Saturation (2477); Ischemic Heart Disease (2493)

Event Date 05/24/2015

Event Type  Injury  

Event Description

Customer reported "during the night of 5/24, pt's adult cushion nasal cannula (lot#0000756067) brand: airlife cat.(b)(4) (25') oxygen tubing coiled and kinked where that soft tubing meets under the chin.This caused the pt's o2 sats to drop into the low 80's and caused a hypoxic ischemic cardiac event.Pt's troponin was checked during the morning of 5/25 ordered by doctor and proved to be elevated to 2.09.Repeat troponin showed 1.77 proving ischemic event.Ekg was unchanged (-) and cxr did still show evidence of chf.It took several hours to bring pt to baseline and ease her respiratory condition.No sample is available as the device was not retained by the customer".Prior to the reported issue patient was oxygen dependent of 3 liters at night.

Manufacturer Narrative

(b)(4) - to date no sample has become available of the product within the reported issue.The user facility also submitted a medwatch report for this reported issue.If any additional information becomes available a follow up emdr will be submitted.

Manufacturer Narrative

(b)(4)- follow up emdr submission- unfortunately, no sample was received for evaluation.The device history record for the lot reported was evaluated for any issues related with this customer report.The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed.No trend has been observed with this product and there have been less than 3 complaints in past 6 months.Without a sample it¿s not possible to confirm if manufacturing personnel contributed to the defect reported.No issues were observed during manufacturing process review.Without a sample is not possible to determine if material contributed with this failure.Without a sample available for evaluation it is not possible to determine if design contributed to this failure.Without the sample it is not possible to determine the root cause of the issue reported, the product sft2625 is being produced per carefusion¿s specification.At this time no corrective action will be implemented, since the reported failure cannot be confirmed.

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: CANNULA SOFT ADULT W/25FT TB 25/CS
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4845383
• MDR Text Key: 5935695
• Report Number: 8030673-2015-00139
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,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: SFT2625
• Device Lot Number: 0000756067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/20/2015; 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 98