MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; PUMP, INFUSION

Catalog Number 20709

Device Problems Occlusion Within Device (1423); Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.

Event Description

The customer contact reported the device did not alarm when occluded.At an unspecified date and time, the device was programmed to deliver hydromorphone.No specific programming parameters were provided.After an unspecified amount of time, it was reported the patient was complaining of pain.At that time, the nurse checked the device to confirm that the dose was delivered.Upon further inspection, it was noted that the tubing was clamped near the patient and no drug had been delivered.There was no report of an occlusion alarm.No reported adverse patient effects and no reported delay of critical therapy to this patient.No medical interventions were required.Additionally, per the customer contact the device was tested at the user facility and no alarm was generated during a "downstream" occlusion.No additional information was provided.

Manufacturer Narrative

The device passed the distal occlusion test.During testing, the device alarmed for an occlusion at 15.3 psi, (specification 15+/- 5.0).The customers report of the device did not alarm when occluded was not confirmed.Based on the data verified, hospira could not attribute the issue to the device.

Event Description

The customer contact reported the device did not alarm when occluded.At an unspecified date and time, the device was programmed to deliver hydromorphone.No specific programming parameters were provided.After an unspecified amount of time, it was reported the patient was complaining of pain.At that time, the nurse checked the device to confirm that the dose was delivered.Upon further inspection, it was noted that the tubing was clamped near the patient and no drug had been delivered.There was no report of an occlusion alarm.No reported adverse patient effects and no reported delay of critical therapy to this patient.No medical interventions were required.Additionally, per the customer contact the device was tested at the user facility and no alarm was generated during a "downstream" occlusion.No additional information was provided.

• Brand Name: LIFECARE PCA 3 V5.06
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; zona franca global,; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global,; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider ; 275 n field drive; bldg. h2-1east, dept no. 097u; lake forest, IL 60645 ; 2242125740
• MDR Report Key: 5411906
• MDR Text Key: 37528317
• Report Number: 9615050-2016-00014
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042800
• 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
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1