MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Device Ingredient or Reagent Problem (2910); Material Integrity Problem (2978)

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

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id :8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 482.6 mcg/day) via an implanted pump.The indication for pump use was cerebral palsy and intractable spasticity.On (b)(6) 2018 it was reported that on (b)(6) 2017 the physician did a pump refill and aspirated over 23 cc of drug when there should have been less than 2 ml.At that point, he put 20 ml back in the pump.A dye study was performed today and he could not aspirate any fluid from the catheter via the catheter access port.He then accessed the pump reservoir and aspirated 15 ml; if the drug was being delivered correctly, there would have been roughly 9.7 ml.He filled the pump with 40 ml of gablofen at the same concentration and dose.With regards to any environmental, external, or patient factors that may have led or contributed to the issue it was noted that they looked at an x-ray and the tip of the catheter remained in the thoracic area.It was noted that it could be a kink at the anchor site, but they were unable to tell.The patient was being referred to get a catheter and pump revision.The surgical i intervention was planned, but not yet scheduled.The issue was not resolved.The patient status was reported as ¿alive ¿ no injury¿.No patient symptoms were reported.No further complications have been reported as a result of this event.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) serial# (b)(4) explanted: (b)(6) 2018 if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that on (b)(6) 2018 the pump and catheter were replaced.The catheter had two very sharp turns coming out of the anchor.Once they released the anchor and straightened out the catheter there was csf (cerebrospinal fluid) flow.The kink was the issue.It was noted that when they aspirated via the catheter access port once the new catheter was placed, the csf was an orange yellowish color.They aspirated at least 2 cc of csf twice and the fluid stayed the same color.They also checked the color of the csf coming out of the original catheter once it was freed up and it had the same color.The fluid was sent for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

The other relevant component includes: product id 8780 (b)(4) implanted: (b)(6) 2014 explanted: (b)(6) 2018 product type catheter.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider.It was reported the cause of the xanthochromic (orange-brown) cerebrospinal fluid was ultimately unknown.Several tests had been ordered on the fluid; including a microbiology and culture, which was negative.It was also indicated xanthochromia, a measure of blood cell breakdown products within the spinal fluid, was also negative.The protein was mildly elevated at 66, above the lab normal (35).Other tests included a normal glucose at 77.The original sample had been taken from the original intrathecal catheter; no spinal fluid was able to be removed from the medication pump.

Manufacturer Narrative

Analysis of the implantable pump (b)(4) identified no anomalies.The returned device passed al functional testing in the laboratory.Analysis of the implantable catheter (b)(4) identified a kink in the catheter body which caused the catheter to become occluded.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7185425
• MDR Text Key: 97069271
• Report Number: 3004209178-2018-00697
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR