| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); No Code Available (3191)
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| Event Date 11/21/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Common device name, g5- pma/510(k) #: these fields are not applicable to the complaint device as it is not sold in the u.S.; however, this device is considered clinically similar to cook upic and cvc devices, thus prompting this report.Customer (person): email: (b)(6).Reporter occupation: unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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It was reported that an infection developed after placement of a redo single lumen tpn catheter set.On (b)(6) 2019, the hospitalized child patient was transferred to a different facility's gastroenterology department due to a sasm (sensitive aureus staphylococcus) infection on the device.The device was previously implanted to be used for parenteral nutrition.As a result, the device was removed.A replacement device was implanted on (b)(6) 2019 and the patient was transferred back to the previous facility.Other events associated with this patient can be found reported under patient identifier (b)(6).Additional information regarding the patient, device, and event has been requested but is currently unavailable.
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Manufacturer Narrative
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This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information regarding the patient was received on 21jul2020.The patient was reported to be "very active".
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Event Description
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No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.Additional information: b7, section c.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Additional information was received on 28aug2020 stating that there was only one event of staphylococcus.Two events of infection have been reported under this event as well as under mdr reference #1820334-2020-01309.It is currently unclear how many events of infection correspond to this patient as two sets of information regarding two individual infections have been previously reported.Cook has contacted the user facility in attempt to gain clarification on the sequence of events for this complaint.The initial reporter no longer works at the user facility, however, the user facility has stated that further attempt to gain clarification will continue.Should information be received, a follow-up mdr will be submitted within 30 days of receiving the information.
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Manufacturer Narrative
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This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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In an email received on 17sep2020, the timeline for this event and the related events associated with patient identifier (b)(6) was confirmed.
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Manufacturer Narrative
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Investigation - evaluation.Chu limoges user facility, located in france, reported an incident to cook on (b)(6) 2020 involving a redo single lumen tpn catheter set (rpn: c-tpns-4.0-65-redo).It was reported that the patient acquired a sasm infection on their catheter.This patient experienced a series of three events of which are reported under mdr ref.#1820334-2020-01309 and mdr ref.The male pediatric patient was diagnosed with trichohepatoenteric syndrome involving the following: liver damage, fine blonde hair, atopic dermatitis (latte stains), rhinoplasty to repair cleft lip and palate, igg/iga immune deficiency, and intrauterine grown retardation (rciu), less than 3rd percentile.The patient¿s activity level was reported to be ¿very active¿.On (b)(6) 2019, it was discovered that the patient had acquired a sensitive aureus staphylococcus (sasm) infection on their redo single lumen tpn catheter.The patient was an inpatient at chu limoges hospital and had a cook redo single lumen tpn catheter to receive total parenteral nutrition (tpn).Following discovery of the infection, the patient was transferred to necker gastroenterology on (b)(6) 2019.The device was removed at necker hospital on (b)(6) 2019 and a new redo single lumen tpn catheter set (rpn: c-tpns-4.0-65-redo, lot number 9514413) was implanted in their left dorsal on the same day.The child was transferred back to chu limoges hospital on (b)(6) 2019.A review of the complaint history, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.As adequate inspection activities have been established and no other information is available in relation to the lot, it was concluded that the device was manufactured to specification and that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The set is supplied with ifu which includes the following in relation to the failure mode: ¿suggested catheter maintenance:.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparanized saline solution.Catheter heperanization should be determined by intuitional protocol and clinical judgement.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before use 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 be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict septic technique must be adhered to while using and maintaining catheter.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile¿.Based on the information provided, no product returned, and the results of the investigation, a root cause was traced to the patient's condition.Cook has concluded that the most probable cause of this event is related to patient pre-existing conditions and possibly the lack of strict aseptic technique while using and maintaining the catheter.The patient suffered from igg and iga immune deficiency; a deficiency in immunoglobins places the patient at a higher risk of infection as these are deficiencies in the immune system.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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