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

Catalog Number AP03000H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).This initial mdr will be the only report submitted for mfr report #1226348-2017-00512.The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that a codman 3000 drug pump (ap0300h/(b)(4)) was implanted on (b)(6) 2017 and explanted due to an infection at the incision site.The patient has a medical history of colon cancer, diabetes, ampullary adenoma, obesity, osteoarthritis.The patient presented with a blister at the incision site that was leaking.It did not heal with local wound care and appeared to be related to the hai pump.The pump was exposed to skin breakdown and was explanted from the patient on (b)(6) 2017.Glycerol was being used in the pump when it was explanted.The patient currently has ned in the liver and is doing well.

Manufacturer Narrative

(b)(4).This follow-up mdr will be the only report submitted for mfr report #1226348-2017-00512.Additional information received on january 03, 2018: the device was received on january 03, 2018.The device has been forwarded to codman and an evaluation is currently underway.Additional information will be provided within 30 days of receipt.

Manufacturer Narrative

Product complaint # (b)(4).Conclusion: pump was returned for evaluation.Visual examination shows scratches on the exterior metal surface of the pump.The septum felt normal with several puncture marks consistent with needle penetration.The pump had a 6.5¿ segment of white catheter attached that was not clamped or tied at the distal end.Approximately 20.452ml of clear fluid with no particles was emptied from the reservoir.The bolus pathway and catheter could be flushed with no resistance.Cloudy yellow fluid with white particulates was collected.Flow path and catheter were patent and anomaly free.No leaks were noted from the septum or catheter when flushing and pressurizing.The reservoir was filled with 30mls of bacteriostatic water and placed in a 37 degree celsius water bath for flow testing.The pump flowed and average of 1.760 ml/ day, 97.8% of specified manufactured flow rate of 1.8 mls/day which is between the expected 85.1% and 114.9%.An erroneous reading was noted on the 3rd flow test reading and was a result of the catheter being inadvertently pinched by the hood of the water bath.This reading was excluded from the results and an additional one was taken to complete the flow test.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process related to the reported complaint.There were no non-conformances related to device manufacture or inspection.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint # (b)(4).This follow-up mdr will be the only report submitted for mfr report #1226348-2017-00512.Additional information received on april 30, 2018: (expiration date): february 28, 2019.

• Brand Name: MODEL 3000 - 30ML VOLUME, HIGH PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 6506874920
• MDR Report Key: 7153706
• MDR Text Key: 96002758
• Report Number: 1226348-2017-00512
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: AP03000H
• Device Lot Number: C61724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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: 74 YR
• Patient Weight: 104