MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HQV 101404#ADULT PACK

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.H3 other text : 4115.

Event Description

It was reported that the tie-wrap (cable tie) is not tightened enough at some connectors.It is causing the hose to come loose.The cable tie can easily be removed with the customers fingers, just pushing it off.Complaint #: (b)(4).

Manufacturer Narrative

It was reported the tie-wrap (cable tie) is not tightened enough at some connectors in a pack.It¿s causing the hose to come loose.The cable tie can easily be removed with the customers fingers, just pushing it off.The clinicians will have to check all the cable ties on these sets.The customer used the products.They took off the tie wraps and putted new ones on that they tightened.No harm to any person was reported.Mcp (antalya) requested 4 packs of bo-hqv 51601#adult pack open, lot number: 3000285143 from gxo stock because used same cable tie, lot number 3000280779.These products were visually checked if there is any loose cable tie.There was no damage on the outer packages.The tyvek cover was fully sealed and there was no damage, hole on it.As a conclusion the excessive forces are unlikely.The products were unpacked carefully and all cable ties were manually checked.The cable ties were found complete and tight.The investigation of the returned samples from the warehouse shows that the cable ties are secured according to the production procedures.There was no loose cable tie was found like reported in this complaint.The cables ties are stored in the cleanroom according to its temperature and storage condition.Based on the investigation results, it could be conclude that the loose cable tie could not be attributed to all products manufactured with same procedures and applied to same in-process controls.Besides, there is no material failure could be identified.The production history record (dhr) of the affected be-hqv 101404 with lot # 3000283297 was reviewed on 2023-10-01.According to the dhr results, the product be-hqv 101404 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.This complaint was shared internally with shift leader, tubing set.Also cable tie guns were checked for securing with cable ties.Force measurement is applied to tie guns to eliminate the the tie guns are tightened the cable tie loosely in accordance with si-b-135 ¿cable tie guns force measurement instruction¿ rev2.Fb-372 "cable tie guns force measurement form" is filled in 3-month periods.Fb-372 records of above tie guns were reviewed, and no deficiency was found.There is only one product was reported in this complaint.The customer also reported complaint #(b)(4).(swedish mpa ref.#6.6.2-2023-084909) the set with loose cable tie.The products in both complaints were used after clinicians re-do all tie-wraps/cable ties on the hoses.No harm to any person was reported.The order (b)(4).(product be-hqv 101404#adult pack) was controlled during production regarding cable tie assembly.The assembly was performed according to production procedures and controlled according to in-process controls.There was no loose cable tie detected also by the senior quality assurance engineer at the time of manufacturing of this lot.The exact root cause remains unknown at this moment.The most probable cause is the cable tie assembled loose, untightened and this was not detected during controls.Besides, employees were informed about this complaint on 2023-10-05.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.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint #: (b)(4).

• Brand Name: TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17805921
• MDR Text Key: 324113784
• Report Number: 8010762-2023-00474
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HQV 101404#ADULT PACK
• Device Catalogue Number: 701076030
• Device Lot Number: 3000283297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1