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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 03-2722-9
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2016
Event Type  malfunction  
Manufacturer Narrative
Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.
 
Event Description
A user facility reported that a blood leak occurred immediately after initiation of the patient's hemodialysis (hd) treatment.The blood leak was noted as being an external bloodline leak from the side of the tubing at the venous med port.The machine did not alarm as it is not intended to do so.No bloodline damage was visible.The patient¿s estimated blood loss (ebl) was noted as being approximately 100cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on the same machine.The complaint device is available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed a crack in the tubing at the injection site location on the venous line.The bloodline was subjected to laboratory leak where the device was submerged in a water bath while pressurized air was forced up to 15 psi for a period of ten minutes into the device.Several air bubbles were observed from the injection site and location of the reported crack.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.The investigation into the cause of the reported problem was able to confirm the failure mode.A visual inspection was performed which confirmed the presence of a crack at the venous line injection site.Additionally, a leak was identified from the location of the observed crack.Therefore, the complaint has been deemed confirmed.
 
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Brand Name
CUSTOM COMBI SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX   88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6122908
MDR Text Key60751022
Report Number8030665-2016-00579
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/09/2017
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 Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number03-2722-9
Device Lot Number16HR01211
Other Device ID Number00840861100293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 10/27/2016
Initial Date FDA Received11/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS 2008T HEMODIALYSIS MACHINE
Patient Age92 YR
Patient Weight50
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