MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.11 ABG; PUMP INFUSION

Catalog Number 20709

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2017

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 a device with a battery that was not charging and a power cord that had a cut.The customer further mentioned that there was no physical damage to the battery, but the power cord had exposed bare wires.There were no reports of any adverse events of delays in critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

Initially the customer contact indicated that the device would be returned for investigation.Subsequently, the device was not received; therefore, testing could not be performed.The device was not returned for investigation, therefore the customer's complaint could not be confirmed due to insufficient information.The probable cause could be due to defective battery or physical damage.

Event Description

The customer contact reported a device with a battery that was not charging and a power cord that had a cut.The customer further mentioned that there was no physical damage to the battery, but the power cord had exposed bare wires.There were no reports of any adverse events of delays in critical therapies while the device was in clinical use.No additional information was provided.

• Brand Name: LC PCA REFURB 802.11 ABG
• 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: regina rose, mba, bs, mt(ascp) ; 600 n. field drive; bldg. h2-1e; lake forest, IL 60045-,USA ; 2242125740
• MDR Report Key: 6711306
• MDR Text Key: 80064940
• Report Number: 9615050-2017-00065
• 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: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• 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: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1