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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICE GROUPCURLIN INFUSION 4000CMS IV PUMP

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MOOG MEDICAL DEVICE GROUP CURLIN INFUSION 4000CMS IV PUMP   Back to Search Results
Event Date 01/11/2010
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

Actual device was evaluated. Performance tests were completed, including the standard accuracy tests, pressure tests and the device was run at the same parameters/settings the customer used. A visual inspection of the device exterior and interior was completed. Exterior damage was noted on battery door, front bezel and rear case. Results: fluid ingress (brown residue) was discovered internally on the pcb, front and back case and various other internal components. Device performed to specifications during the performance tests conducted at moog. Could not duplicate the failure. Fluid ingress likely caused short circuits, which led to the pump communication signals to be adversely affected; i. E. Signals did not get sent or signals were not received correctly due to the presence of fluid on the pcb components. Conclusion: device failure (fluid ingress shorted the pcb) caused by external damage and subsequent fluid ingress directly caused pump to not detect over delivery. Device experienced 53 alarms (13 error code 10, 11 error code 15 and 29 occlusion) from (b) (6) before the over delivery occurred. The pump had obvious problems and the labeling clearly states if there is damage, shows repeated error codes or indicates its not performing correctly to return the pump to the health care provider/manufacturer. The device passed all functional/performance criteria. Over delivery could not be duplicated. The information in this report does not constitute an admission that the product caused or contributed to the incident.

 
Event Description

An (b) (6) year old, terminally ill (end stage cancer), home hospice, patient, was ordered an infusion of dilaudid with a continuous basal rate of 0. 5mg/hr of 500mg in a 0. 5mg/hr as needed every 15 minutes. While the nurse was programming and attempting to run the pump, it experienced 41 error codes or alarms. A replacement pump was attempted and also experienced error codes. The caregiver returned to this pump ((b) (4)) and then it infused for about 2 hours. At that point the pump experienced an up occlusion alarm and the bag was observed to be empty and the patient had deceased.

 
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Brand NameCURLIN INFUSION 4000CMS IV PUMP
Manufacturer (Section F)
MOOG MEDICAL DEVICE GROUP
huntington beach CA
Manufacturer (Section D)
MOOG MEDICAL DEVICES GROUP.
salt lake city UT
Manufacturer Contact
shirley hyink
4314 zevex park lane
salt lake city , UT 84123
(801) 264 -1001
Device Event Key1643998
MDR Report Key1600975
Event Key1523184
Report Number1722139-2010-00005
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/13/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/11/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

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