MAUDE Adverse Event Report: CAESAREA MEDICAL ELECTRONICS LIMITED BODY GUARD; PATIENT CONTROLLED ANALGESIA PUMP

Device Problems Device Alarm System (1012); Occlusion Within Device (1423); Failure to Infuse (2340); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

Discovered on skilled nurse visit that pt pain pump was not infusing.Volume in bag had not decreased in accordance with settings on the pump and with nurse visual inspection of volume in the 150ml bag.Pain pump had been initiated on (b)(6) 2014 and date of discovery of problem was date of this report on (b)(6) 2014.Upon inspection the volume in the bag was estimated at being full.(150 ml).Later discovered that tubing in the door of pump was collapsed; however, the pain pump never alarmed or gave warning of an occlusion, even when nurse clamped tubing and tried to give bolus dose of medication during her home visit.Pca pump provided by (b)(6).

• Brand Name: BODY GUARD
• Type of Device: PATIENT CONTROLLED ANALGESIA PUMP
• Manufacturer (Section D): CAESAREA MEDICAL ELECTRONICS LIMITED; 16 shacham; caesarea 3890 0; IS 38900
• MDR Report Key: 4308423
• MDR Text Key: 5135285
• Report Number: 4308423
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Distributor Facility Aware Date: 10/03/2014
• Event Location: Other
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 59