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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ATLACOMULCO HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - ATLACOMULCO HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number BBC8314P
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2017
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a homechoice cassette was leaking from a rupture in the patient line of the cassette during fill one of five.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
One actual device and twelve (12) retention samples were received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection of the actual sample was performed with the naked eye and a cut in the tubing was noted.A visual inspection was performed to the primary package finding that it also presents a cut.The position of the cut in the primary package matches with the position of the cut in the patient line.An integrity test was performed to the actual sample, obtaining unsatisfactory results, the leak was detected.The reported condition was verified.The assignable cause of the leak was determined to be a cut in the tubing of the patient line.An assignable cause of the cut could not be determined.A visual inspection of the twelve (12) retention samples was performed and there were no visually detectable perforations or damage.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - ATLACOMULCO
altacomulco
Manufacturer (Section G)
BAXTER HEALTHCARE - ATLACOMULCO
av. ing. salvador sanchez
colin no. 9
atlacomulco CP504 50
MX   CP50450
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6949822
MDR Text Key89742710
Report Number1416980-2017-08311
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/06/2017
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 Lay User/Patient
Device Catalogue NumberBBC8314P
Device Lot Number01YGHC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/20/2017
Initial Date FDA Received10/13/2017
Supplement Dates Manufacturer Received10/30/2017
Supplement Dates FDA Received11/06/2017
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 N
Patient Sequence Number1
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