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U.S. Department of Health and Human Services

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

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ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 03-2962-3
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.No further testing was done on a companion sample as the entire lot has been sold and distributed.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the actual 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 non-conformances or any associated rework identified during the manufacturing process which could be associated with the reported event.In addition, the lot passed all in-progress and final qc testing and passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.Therefore, the complaint has been deemed unconfirmed.
 
Event Description
A nurse reported that during a home hemodialysis (hd) patient's treatment, the patient reportedly observed air bubbles in the blood lines.Follow-up with the patient confirmed that sometime before the month of (b)(6), the 2008k@home machine alarmed for air detected approximately 3/4 of time into the hd treatment.The patient had ended treatment and started to do a manual return of his blood.The patient was able to return 3/4 of the blood within the extracorporeal circuit.The patient's estimated blood loss (ebl) was noted as being approximately 1/4 of the blood that was left in the circuit.The patient did not set up with new supplies to complete the rest of treatment.The patient was able to successfully complete his next scheduled treatment.There were no patient adverse effects and no medical intervention was required as a result of this event.The patient continues to have successful home hd treatments.No damage to the bloodline tubing set was visible.The bloodline complaint device is not available to be returned to the manufacturer as it was discarded by the patient.The machine alarmed for air appropriately.Recently, the patient's associated clinic sent a biomedical technician to the patient's home to verify the machine's operational integrity.Functional testing performed by the biomed confirmed the unit was operating properly.The machine passed all functional tests and remains in use by the patient.
 
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Brand Name
HOME HEMO 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 johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6086128
MDR Text Key59466583
Report Number8030665-2016-00559
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/08/2016
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 Expiration Date01/31/2019
Device Catalogue Number03-2962-3
Device Lot Number16AR01291
Other Device ID Number00840861100330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 10/13/2016
Initial Date FDA Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2016
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 2008K@HOME HEMODIALYSIS (HD) MACHINE
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