MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MODEL 3000 - 30 ML VOLUME, LOW; PUMP, INFUSION, IMPLANTABLE, PROGRAMMABLE

Model Number	AP-03000L
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Overdose (1988); Respiratory Distress (2045); Dizziness (2194)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr was a previous codman & shurtleff mdr and was reported under manufacturer report number 1226348-2019-00984.This event occured on (b)(6) 2019 and was reported to codman 11 sep 2019.The complaint was investigated and attempts were made by codman to retrieve the device for a physical examination as part of the investigation.After being unable to retrieve the device, codman closed the complaint on 17 jan 2020.Intera oncology acquired the drug delivery business from codman & shurtleff in (b)(4) on 08 jun 2020.Intera oncology was notified in 19 aug 2020 that the device in this complaint was explanted on (b)(6) 2020 and was being shipped to codman.The device was forwarded to intera oncology for evaluation and received on 31 aug 2020 at the decontamination facility.The device will be evaluated and a supplemental mdr will be filed upon completion of the investigation.
Event or Problem Description
A report was received that during a refill procedure of a codman model 3000 - 30ml volume, low constant flow drug infusion pump ap03000l / lot# 9949/ serial # (b)(4)), a malfunction occurred during the refill procedure on (b)(6) 2019, and the pump unintentionally pumped a large amount of medication into the patient.It was reported that post-refill, approximately 5-10 minutes, the patient experienced leg heaviness, dizziness and a decreased in blood pressure.The patient's respiratory status was also affected, and urgent interventions were required to support breathing.Reversal medications were delivered, the pump was accessed to remove (aspirate) residual medication, the patient was emergently intubated and admitted to the intensive care unit (icu) for treatment and monitoring.The pump remains implanted in the patient but is no longer being used.The patient has been placed on oral medications and was discharged to home on (b)(6) 2019, in stable condition.Follow-up with care providers has been arranged for alternate treatment plan.The patient will undergo revision surgery to remove the pump.The date of the pump explantation is unknown at this time.The patient received the pump implant on (b)(6) 1999, to treat complex regional pain syndrome (crps) and would regularly come in every 6-8 weeks to have it refilled with hydromorphone (10 mg/ml), baclofen (0/36 mg/ml), and bupivacaine (2.5 mg/ml).The last refill date was on (b)(6) 2019.There was 1.4 ml residual volume in the pump reservoir.At the most recent refill procedure on (b)(6) 2019, 30 ml of drug comprised of the above-mentioned solution was placed in the pump reservoir using a 22-gauge bevel needle without any difficulty or issue.The drug concentration/mixture was verified to be correct as per standard practices by physician.The reporting physician thinks that the pump has reached its end of life and that it is no longer working as designed.It was further stated that the internal pump valve likely malfunctioned resulting in a bolus infusion.The overdose was not thought to be related to a pocket fill and there was no evidence to suggest that the septum was inadequate.The pump did not appear damaged.The patient did not have a fever and did not experience any changes in elevation.
Additional Manufacturer Narrative
Intera performed evaluation of the explanted device for flow rate and inadvertant bolus test.The device flow rate was within specification as manufactured.The device passed the inadvertant bolus test, meaning that the device did not have any bolus flow upon attempted refill.Therefore, the complaint could not be confirmed or traced to device function or performance.The previous investigation noted that the customer stated the refill was not performed as stated in the ifu.Unintentional bolus can occur if the incorrect needle is used to perform the refill.The drug combination was hydromorphone, baclofen, and bupivacaine.The codman 3000 is ony indicated for baclofen and morphone sulfate; uses of other drugs for intrathecal use is considered off-label.Patient information was not provided from the healthcare provider.Blank fields in the mdr form indicate that information is not available.

• Brand Name: MODEL 3000 - 30 ML VOLUME, LOW
• Common Device Name: PUMP, INFUSION, IMPLANTABLE, PROGRAMMABLE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynahm MA 02767
• MDR Report Key: 10537986
• Report Number: 3015537318-2020-00005
• Device Sequence Number: 19444378
• Product Code: LKK
• UDI-Device Identifier: 10886704043607
• UDI-Public: 10886704043607
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2001
• Device Model Number: AP-03000L
• Device Catalogue Number: AP03000L
• Device Lot Number: 9949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention