MAUDE Adverse Event Report: COOK INC COOK SPECTRUM TURBO-JECT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number G34548

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name: turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that central line not working due to precipitant in line.According to the initial reported, the patient required to have the picc line re-wired.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: (information below was available at the time the initial report was submitted).The medications that were going thru the line are tpn and fat emulsion and blinatumomab, morphine, and lotrimin oxazole.Implant date: (b)(6) 2018.Additional information below has been requested but the manufacturer has yet to receive a response.Date of event.How long was device in place before failure occurred? where in the body was the device implanted? investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification/functional test of the returned device were conducted during the investigation.Clinical assessment:tpn precipitate is a potential adverse event that occurs more with calcium and phosphate solubility related or when the products reach room temperature.¿formulations that appear stable when refrigerated could form precipitates at room temperature.The amounts of calcium and phosphate added must be considered, with a greater chance of precipitation if the amount of one or both is increased above standard¿ (miller, et al).Also, another reference (newton et al) refers to an ¿april 1994 safety alert, several publications on calcium phosphate precipitation in tpn formulations appeared.There is no mention that there was anything physically wrong with the device when it was inserted.The device had been placed 13april2018 but there is no information about the device removal.At this time, the most probable cause of this event is medication/tpn compatibility related.Citations from sarah j.Miller, pharmd, us pharm.2006;7:hs-10-hs-20 and newton, david w.Am j health-syst pharm.2008; 65:73-80.Http://ahfs.Ashp.Org/hid/r2803.Pdf./ the customer returned one double lumen upic in a used condition.The catheter tubing extends approximately 35.5 cm from the hub.There does not appear to be any damage ton either adapter.There does not appear to be damage on the manifold, either lumen or the catheter shaft.Bio-matter is present on the device.The device was wet upon opening.Liquid appeared to be residing in the catheter tubing.A leak test was performed by clamping the tubing with hemostats and injecting room temperature water through the proximal hub with a syringe.No leak was identified.When flushing through the orange adapter, water flowed freely from the distal end of the catheter tubing.However when attempting to flush from the white adapter, resistance was met.Palpating the extension tubes and catheter tubing was not able to determine the presence of any blockage.The white adapter extension tube was bisected and thick brown bio-matter was noted.No other cause for occlusion was found.The od of the extensions tubes were within manufacturing specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with instruction for use (ifu) which notes: the catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (crbsis).The cook spectrum turbo- ject picc is indicated for multiple injections of contrast media through a power injector.The maximum pressure limit setting for power injectors used with spectrum turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown on the following table.For a 4french double lumen catheter, the orange hub's flow rate is 3ml/sec and injection pressure limit is 325 psi.The white lumen doesn't get power injected.Based on the information provided, the examination of the returned product, and the results of our investigation, a likely contributing root cause was determined to be is product use and handling related (caused by another drug/device).We have notified the appropriate personnel and 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.

• Brand Name: COOK SPECTRUM TURBO-JECT
• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7513703
• MDR Text Key: 108231342
• Report Number: 1820334-2018-01468
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)190816(10)8577869
• Combination Product (y/n): N
• PMA/PMN Number: K133634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G34548
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Date Manufacturer Received: 06/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention