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

Catalog Number 03-2722-9

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical engineer (biomed tech) from a user facility reported of particulate inside the dialyzer.He reported it appeared as if a splinter of wood came from the dialyzer and was caught in the venous chamber of the blood line.Upon further inspection, another particulate was also found in the bottom cap.Additional follow-up with the biomed tech indicated the issue was discovered during priming and confirmed there was no patient involvement or injury.There was no observed damage to the dialyzer or line.The sample was available to be returned for evaluation.

Manufacturer Narrative

Occupation: other - biomedical engineer plant investigation: the complainant facility returned one f180nre dialyzer attached to blood line (bl) for investigation.The bl visual inspection determined the drip chamber was returned cut open and no other issues or particulates were found.A specimen cup was also received with a particulate resembling a wood splinter.Emails attached in the contents tab indicate that this splinter was removed from the bloodline drip chamber by the complainant and transferred to the specimen cup for return.A photo of the object prior to removal from drip chamber was received.In addition of visual inspection, water was introduced to the bl to locate any other particle, no other particles were found at the bl.During the visual inspection to returned dialyzer a brown /tan colored particulate was noted between the polyurethane cut surface and the screw flange (header end cap).Both particulates were forwarded to the quality systems technical development group (qstdg) for analysis and identification, who matched both particulates to the same cellulosic substance (pine wood) which correlated at 95.3%.The returned particulates were analyzed and identified to be composed of pine wood.A supplemental investigation was conducted; controls are in place and the frequency/risk of this type of event is at an acceptable rate.There are no other complaints reported against the lot and there is no indication of any systemic issue found during production.Multiple potential sources of the particulates were evaluated, however; a conclusive source for the wood particulates could not be identified.In conclusion, the returned particulates found in the header and returned in a specimen cup were analyzed and identified to be composed of pine wood.The device history record [dhr] of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved met specification.

Event Description

A biomedical engineer (biomed tech) from a user facility reported of particulate inside the dialyzer.He reported it appeared as if a splinter of wood came from the dialyzer and was caught in the venous chamber of the blood line.Upon further inspection, another particulate was also found in the bottom cap.Additional follow-up with the biomed tech indicated the issue was discovered during priming and confirmed there was no patient involvement or injury.There was no observed damage to the dialyzer or line.The sample was available to be returned for evaluation.

• 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 Key: 7113082
• MDR Text Key: 95080469
• Report Number: 8030665-2017-01097
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17HR01042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1