MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number CUSTOM TUBING SET

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.A follow-up medwatch will be sent when further investigation becomes available.

Event Description

It was reported that customer found damaged packages in the inner carton and also some of the product damaged on the sterile wrapper (tyvek cover).Complaint #: (b)(4).

Manufacturer Narrative

It was reported that customer found damaged packages in the inner carton and also some of the product damaged on the sterile wrapper (tyvek cover).The pictures were provided in regards to the failure.Pictures are showing the damage to the separator inside the outer box - at the top of tyvek -.There are marks on the separator and accordingly on the tyvek.No outer box damage could be seen in the pictures.Additionally, it was reported that the outer pack has no damage.4 packs have marks on tyvek cover however only 2 of them were damaged and not sterile anymore.Device history record (dhr) for lot #92302824 was reviewed on 2021-05-09.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.There is 100% visual inspection according to 6 eye principle for tyvek lid and for cardboard boxes.Furthermore, there is visual control in accordance with basic operation procedure 9201233 states, tubing set is placed inside the tray in order according to the technical drawing or picture instructions.Dhr review shows appropriate manufacturing documentation and production step controls were in place.It was suspected within this complaint that the overturning force was applied to the packs and consequently products in the packs caused damages and marks on the tyvek and accordingly on the inner carton (separator).The failure mode 'failure of sterile packaging' also can be linked to the following most possible root causes according to risk management file of the product tubing sets dms #dms# 1906296, v19: - transport of product the investigation result of this complaint confirms that the products met the release criteria at the time of manufacturing and no damage cardboard damage was reported.Therefore, it could be concluded that excessive physical force was applied to packs during transportation from the manufacturer to the customer.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.

Event Description

Complaint #: (b)(4).

• Brand Name: TUBING SET
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11832090
• MDR Text Key: 250862956
• Report Number: 8010762-2021-00299
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

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: 08/07/2022
• Device Model Number: CUSTOM TUBING SET
• Device Catalogue Number: 70106.9179
• Device Lot Number: 92296053
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/26/2021
• Patient Sequence Number: 1