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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 03-2742-9
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2017
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 at the end of a patient's hemodialysis (hd) treatment while the venous line was being rinsed back.The blood leak was noted as being a bloodline tubing leak.Reportedly, a separation occurred at the connection between the saline and arterial lines.The machine did not alarm as it is not intended to do so.The external blood leak was visually observed at the location of the line separation.The patient¿s estimated blood loss (ebl) was noted as being approximately 250 cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The hd treatment was complete when the incident occurred so the patient did not need to be re-setup.Follow-up was provided which revealed that there was no damage observed to the bloodline packaging.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
 
Manufacturer Narrative
The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.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 material and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
 
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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 Key6391640
MDR Text Key69520659
Report Number8030665-2017-00102
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 04/05/2017
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 Date09/30/2019
Device Catalogue Number03-2742-9
Device Lot Number16LR01293
Other Device ID Number00840861100309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 02/14/2017
Initial Date FDA Received03/09/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2016
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; OPTIFLUX F180NRE DIALYZER FINISHED ASSY.
Patient Age53 YR
Patient Weight80
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