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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; PUMP, INFUSION, ENTERAL

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NELLCOR PURITAN BENNETT MEXICO SA KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 765559
Device Problem Complete Blockage (1094)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Submit date: (b)(6) 2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that during the second feeding, the flexible tube always gets clogged in the flexible tubing near the end that connects to the joey pump and they are unable to unclog it.This has occurred numerous times with this patient.No patient injury.
 
Manufacturer Narrative
Patient codes, was corrected.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that during the second feeding, the flexible tube always gets clogged in the flexible tubing near the end that connects to the joey pump and they are unable to unclog it.This has occurred numerous times with this patient.No patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the complaint and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
Manufacturer (Section G)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX   22225
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6743539
MDR Text Key81012484
Report Number1282497-2017-05243
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number765559
Device Catalogue Number765559
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/26/2017
Initial Date FDA Received07/26/2017
Supplement Dates Manufacturer Received06/26/2017
06/26/2017
08/08/2018
Supplement Dates FDA Received07/26/2017
07/09/2018
10/05/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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