MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number H 99100

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) will not be able to investigate the product as it will not be available for manufacturer's investigation.Due to the internal clinical assessment it is possible that a higher traumatization of the blood could be given which leads to a higher clotting risk.Anyway these factors are always given when a heart-lung-machine is used.The manufacturer is aware of a similar complaint showing a similar malfunction.This similar event occurred at the same hospital.The products of this similar complaint has been requested but were not received.As soon as the investigation of this similar complaint has been finished a supplemental medwatch will be submitted.Additional information: the product mentioned under section is a tubing set and the included affected component has the contributing design function of the blood filter which is registered under 510(k): k001787.

Event Description

Description from the customer report: "after priming procedure and starting circulation perfusionist noted filter pall al3 is conversely mounted.Unfortunately blood was already in.There was no consequence for patient.Contaminated set is not available for investigation." (b)(4).

Manufacturer Narrative

The received complaint has been investigated by (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.All the controls were done according to the process control form.Moreover, no scrap record for the related pall filter was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a failure caused by a operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet turkey have been informed about the complaint.As soon as further information becomes available a supplemental medwatch will be submitted.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) will not be able to investigate the product as it will not be available for manufacturer's investigation for the complaint #(b)(4), because contaminated set was throwed away by hospital.On the other hand,4 sets were available for investigation, and the product was received for evaluation under complaint #(b)(4).Based on this investigation, the filter has been inspected visually and it was found that the filter has been installed incorrectly.Additionally, the received complaint has been investigated by maquet cardiopulmonary (b)(4).Thereby a device history record of the reported lot has been investigated and no abnormality was found.Based on the received picture the reported failure could be confirmed by maquet (b)(4).The most probable cause was determined as a assembly failure caused by an operator mistake.As a corrective action a training has been performed with the explanation of the assembly of the filter.Furthermore the operators of maquet (b)(4) have been informed about the complaint.Additionally, a review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: HLM TUBING SET
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5772914
• MDR Text Key: 49538437
• Report Number: 8010762-2016-00426
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2017

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: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: H 99100
• Device Catalogue Number: 70106.3568
• Device Lot Number: 92165707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/08/2016; 08/12/2016; 04/06/2017
• Date Device Manufactured: 05/01/2015
• 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