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Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.Reporter postal code: (b)(6).Reporter occupation: unknown.Report source other: competent authority; dkma ref (b)(4).Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
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It was reported that a cook tpn triple lumen tpn catheter set was found to be ruptured and leaking.The device was placed in the jugularis interna right and secured to the patient using sutures and a bandage.When not in use, the catheter was maintained with a heparin lock.The patient was reported to be bedridden.On (b)(6) 2020, while flushing the device, the nurse discovered that there was water bubbling out of the catheter, just before it splits into three lumens.No other problems were noted with flushing or drawing fluids.A 2ml and 10ml syringe were used to flush the device.It was originally reported that the device had been indwelling for 4 weeks.The catheter was subsequently removed and replaced under full anesthesia.No complications were noted during the replacement procedure.It was later reported by the nurse that the cvc kinked over the assembly ("on the line before the cvc is divided into 3 lines").The cvc catheter had kinked the whole morning and the infusion pump had been messaging "high pressure" on and off.The nurse attempted several times to twist the catheter so it would not kink, but it did not provide a long term solution.As soon as the patient turned, the line kinked again.The nurse felt that the catheter felt fragile and flat because it had been turned so much.The nurse then disconnected the catheter so the patient could bathe.There was no pressure at all in the first lumen, which was flushed with 10ml heparinized saline.When flushing the other 2 lumens, there was minimal pressure, but suddenly the water "rejected" when it was flushed carefully.A crack was then noted in the catheter, with blood leaking out.Antibiotic gel and a tegaderm bandage were then placed over the catheter.After this, gauze and an arterial clamp were placed on the catheter to stop the bleeding.It was reported at this time that the device was placed on (b)(6) 2020.It has been reported that since the incident, the patient has passed away due to issues unrelated to the complaint device.
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Investigation / evaluation: as reported by (b)(6) hospital, a cook tpn triple lumen tpn catheter set (part number: c-tpns-8.0t-90, lot number: 9011344) was found to be ruptured and leaking.The device was placed on (b)(6) 2020 in the right internal jugular vein of a bedridden patient and was secured with sutures and a bandage.The device was maintained with a heparin lock when not in use.On (b)(6) 2020, the nurse reported that the device kinked "on the line before the cvc is divided into 3 lines".The catheter had reportedly kinked the whole morning and the infusion pump had messaged ¿high pressure¿ on and off.The nurse had reportedly attempted to twist and un-kink the catheter multiple times; however, as soon as the patient turned, the catheter would kink again.The nurse reported that the catheter felt flat and fragile.The device was disconnected for the patient¿s bath.As the first lumen of the device was flushed with 10 ml of heparinized saline, there was reportedly no pressure.As the other two lumens were flushed, minimal pressure was felt, and the fluid ¿rejected¿ when it was flushed.The nurse reported that fluid was bubbling from the catheter, just before it split into three lumens.A crack was then noted in the catheter with blood leaking out.Antibiotic gel and a tegaderm bandage were placed over the catheter.An arterial clamp was then placed on the catheter to stop the bleeding.No other problems had been noted with flushing or drawing from the device.Both 2ml and 10ml syringes were reportedly used to flush the device.The catheter was removed and replaced under full anesthesia.No complications were noted during the replacement procedure.It has been reported that since the incident, the patient has passed away due to issues unrelated to the complaint device.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device were conducted during the investigation.One used complaint device and 3 unused devices were returned to cook ireland for a related complaint for shipment onto cook inc in the usa (manufacturer).However, the shipment has experienced difficulties clearing customs and as of 21aug2020, after 30 days transit, still has not been delivered.Cook has considered these items lost.A review of the distribution center records indicated that all products from lot: 901131344 had been distributed to customers by 16apr2019, meaning that a sample from the same lot could not be reviewed.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record for the set lot and the catheter component lot revealed no related nonconformances.There are two additional complaints on this device lot from the same facility for the same failure mode reported in mdr reports#: 1820334-2020-01286 and #: 1820334-2020-01289.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: warnings: extreme caution must be used in placement and monitoring placement into the subclavian vein may result in compression of the catheter by the clavicle and first rib.Excessive compression may result in catheter damage, including rupture or catheter embolus.Compression of the catheter and consequent risk may be minimized by placement lateral to the junction of the clavicle and first rib or use of alternative venous sites.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.Subcutaneous catheter placement with curved hemostat 9.Verify the catheter tip position radiographically and close all wounds.The catheter can then be sutured to the skin and dressed in a standard fashion.Suggested maintenance if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc2000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause for failure was traced to unintended user error.A clinical assessment of the complaint concluded the cause of this event this event is likely to be traced to user/procedural issues during routine care and maintenance of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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