MAUDE Adverse Event Report: ABBOTT IRELAND - SLIGO PATROL FEEDING SET; TUBES, GASTROINTESTINAL AND ACCESSORIES

Catalog Number M433

Device Problems Loss of or Failure to Bond (1068); Insufficient Flow or Under Infusion (2182)

Patient Problems Hypoglycemia (1912); Weight Changes (2607)

Event Date 02/16/2015

Event Type  Injury  

Event Description

"same case as 9610175-2015-00001, 9610175-2015-00002, 9610175-2015-00003 and 9610175-0004".Abbott nutrition (b)(4) was notified on (b)(6) 2015 that two additional lot numbers were involved.It was reported the patrol feeding sets broke apart before they went around the pump's rotor.This begun to occur in (b)(6) 2014.When the patient missed a portion of his feedings; his blood glucose decreased to 38-54 mg/dl.The patient did not experience any signs or symptoms of hypoglycemia nor were there any reports of medical interventions provided to return patient to his baseline blood glucose level.It was reported patient weighed (b)(6) in (b)(6) and at the end of (b)(6) 2015, he weighed (b)(6).

Manufacturer Narrative

(b)(4).The device reported, list number m433, is an abbott product that is marketed internationally, which is the same or similar to a device, list number 56841, that was marketed domestically.Abbott nutrition's standard procedure includes attempting to obtain all required information from the source.A total of five batches were involved: (1) 26958vm (2) 27996vm (3) 96222vm (4) 25878vm (5) 20620vm.The batch history record reviews were found to be accurate with no abnormalities.Abbott nutrition (b)(4) was made aware of two additional batch number on (b)(4) 2015.

Manufacturer Narrative

Follow up for manufacturer report number 9610175-2015-00005.The method, results and conclusions for the sister sample returned by the customer is reported on the first row for patrol feeding set list number m433, lot# 20620vm.The sister sample tested with no tubing separations noted.Hence, the complaint is not confirmed.The method, results and conclusions for the sister sample retained by abbott are depicted on the second row.It is noted the batch history record review of a retained sample by abbott for lot# 20620vm showed no abnormalities per visual examination.

• Brand Name: PATROL FEEDING SET
• Type of Device: TUBES, GASTROINTESTINAL AND ACCESSORIES
• Manufacturer (Section D): ABBOTT IRELAND - SLIGO; mfg. site #9610175; ballytivnan; sligo ; EI
• Manufacturer (Section G): ABBOTT IRELAND - SLIGO; mfg. site #9610175; ballytivnan; sligo ; EI
• Manufacturer Contact: fabrizis l. suarez ; 3300 stelzer road; columbus, OH 43215-1724 ; 6146246245
• MDR Report Key: 4531196
• MDR Text Key: 5511265
• Report Number: 9610175-2015-00005
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: M433
• Device Lot Number: 20620VM
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 41