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510(k)

Registration & Listing

Adverse Event Report

CODMAN & SHURTLEFF, INC. ARROW CONSTANT FLOW IMPLANTABLE PUMP

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Catalog Number AP-03000-L

Event Date 01/09/2003

Event Type Injury Patient Outcome Required Intervention;

Event Description

It was reported that pump was implanted in 01. Only morphine was used and the pump functioned properly. The following month the pump was emptied and the return measured 14. 9ccs which was not correct. The pump was emptied and refilled with 30cc morphine. 2 months later, return volume was 29cc. The pump was explanted.

Manufacturer Narrative

See h10.

Manufacturer Narrative

The pump has been returned for eval. Results will be forwarded to the fda upon completion of the eval.

Manufacturer Narrative

Microscopic exam of the exterior surfaces of the pump including the septum did not reveal anomalies. The silicone catheter attached to the pump was compromessed/pinched by the slid clamp to the pump not be flushed. Once the catheter was cut (proximal to the slide clamp) the bolus pathway and catheter could be flushed with no resistance. This pump did not flow following the guidelines in the instructions for use manual, however; flow was initiated at 60 celsius. The high temperature required to initate flow in the lab may suggest air was introduced to the flow path during the shipping and handling process. Once flow was initiated, pump flowed within manufactured specifications. The complaint of "no flow" could not be reproduced in the lab.

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Brand Name

ARROW CONSTANT FLOW IMPLANTABLE PUMP

Type of Device

IMPLANTABLE PUMP

Baseline Brand Name

MODEL 3000 30ML LOW FLOW PUMP

Baseline Generic Name

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Baseline Catalogue Number

AP-03000-L

Baseline Device Family

MODEL 3000 30ML MED FLOW PUMP

Baseline Device 510(K) Number

Baseline Device PMA Number

P890055

Baseline Shelf Life Information

Yes

Baseline Preamendment?

Transitional?

510(K) Exempt?

Shelf Life(Months)

Date First Marketed

03/11/1996

Manufacturer (Section F)

CODMAN & SHURTLEFF, INC.

1600 providence hwy

walpole MA 02081

Manufacturer (Section D)

CODMAN & SHURTLEFF, INC.

1600 providence hwy

walpole MA 02081

Manufacturer (Section G)

CODMAN & SHURTLEFF, INC.

1600 providence highway

walpole MA 02081

Manufacturer Contact

matthew king

325 paramount drive

raynham , MA 02767

(508) 828 -3212

Device Event Key

428782

MDR Report Key

439846

Event Key

416314

Report Number

1226348-2003-00026

Device Sequence Number

Product Code

LKK

Report Source

Manufacturer

Source Type

Health Professional,User facility

Reporter Occupation

Physician

Type of Report

Initial,Followup

Report Date

01/09/2003

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

Date FDA Received

01/29/2003

Is This An Adverse Event Report?

Yes

Is This A Product Problem Report?

Device Operator

Health Professional

Device Catalogue Number

AP-03000-L

Device LOT Number

7566

Was Device Available For Evaluation?

Device Returned To Manufacturer

Date Returned to Manufacturer

01/15/2003

Is The Reporter A Health Professional?

Yes

Was the Report Sent to FDA?

Date Manufacturer Received

01/09/2003

Was Device Evaluated By Manufacturer?

Yes

Is The Device Single Use?

Yes

Is this a Reprocessed and Reused Single-Use Device?

Is the Device an Implant?

Yes

Is this an Explanted Device?

Type of Device Usage

Initial

Database last updated on January 06, 2009

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Center for Devices and Radiological Health / CDRH